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Alere San Diego, Inc.

Last updated September 17, 2026

About

With point-of-care diagnostics, everyday moments can lead to better global health outcomes. Abbott is committed to developing point-of-care diagnostic tests that are able to provide invaluable answers to doctors, clinicians and nurses at just the right time and where they are most needed.

Translated from the manufacturer's own website. Source

Information

Country: US
Address: 829 Towne Center Dr, Pomona, CA, 91767
Website: www.globalpointofcare.abbott
LinkedIn: linkedin.com/company/abbott-
Facebook: facebook.com/Abbott
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2020952
DUNS Number: —

Catalogue (152)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
AlereTM	92217	FDA UDI	Class II	Active
Alere Cholestech LDX®	14875	FDA UDI	Class I	Unknown
SureStep™ Urine Test Drug Screen Strip	DCO-101	FDA UDI	Class II	Active
Alere Cholestech LDX®	10-987	FDA UDI	Class I	Unknown
SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup	DBO-187-011	FDA UDI	Class II	Active
CERTUM OPI One Step Opiate Test Strip	DOP-101-a-Sgl	FDA UDI	Class II	Active
Clearview®	92401	FDA UDI	Class II	Unknown
CERTUM One Step Multi-Drug Screen Panel	DOA-164-141-a	FDA UDI	Class II	Active
Alere Cholestech LDX®	88769	FDA UDI	Class I	Unknown
CERTUM AMP One Step Amphetamine Test Strip	DAM-101-a-Sgl	FDA UDI	Class II	Active
SureStep™ Urine Test Drug Screen Strip	DMT-101	FDA UDI	Class II	Active
Alere Triage®	98201	FDA UDI	Class I	Unknown
Clearview®	92002	FDA UDI	Class I	Active
SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000)	DME-101-a-Sgl	FDA UDI	Class II	Active
SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 300)	DCO-101-a-Sgl	FDA UDI	Class II	Active
Alere Cholestech LDX®	99021	FDA UDI	Class II	Active
CERTUM One Step Multi-Line Drug Screen EZ Split	DBO-167-301-a	FDA UDI	Class II	Active
CERTUM One Step Multi-Line Drug Screen EZ Split	DBO-1107-401-a	FDA UDI	Class II	Active
SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup	DBO-177-161	FDA UDI	Class II	Active
SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500)	DME-U101-a-Sgl	FDA UDI	Class II	Active
SureStepTM Urine Test Drug Screen Strip, Phencyclidine (PCP 25)	DPC-101-a-Sgl	FDA UDI	U	Active
Alere Triage®	98100EU	FDA UDI	Class II	Unknown
Alere Triage®	97000HS	FDA UDI	Class II	Unknown
SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup	DBO-1107-401	FDA UDI	Class II	Active
SureStep™ Urine Test Drug Screen Strip	DBZ-101	FDA UDI	Class II	Active
SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300)	DBA-101-a-Sgl	FDA UDI	Class II	Active
Alere Triage®	98000XR	FDA UDI	Class II	Unknown
SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300)	DBZ-102a	FDA UDI	Class II	Active
CERTUM AMP One Step Amphetamine Test Strip	DAM-A101-a-Sgl	FDA UDI	Class II	Active
SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup	DBO-137-071	FDA UDI	Class II	Active
SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 150)	DCO-U101-a-Sgl	FDA UDI	Class II	Active
SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup	DBD-1107-092	FDA UDI	Class II	Active
Cholestech LDX™	88773	FDA UDI	Class I	Active
SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)	DBZ-101-a-Sgl	FDA UDI	Class II	Active
Alere Triage®	92000	FDA UDI	Class II	Unknown
Alere Cholestech LDX®	10-988	FDA UDI	Class I	Unknown
Alere Triage®	97022HS	FDA UDI	Class II	Unknown
Signify®	01P48-25	FDA UDI	Class II	Active
AlereTM	92211	FDA UDI	Class II	Active
Integrated E-Z Split Key Cup II	DOA-157-062-19-ONW02B	FDA UDI	N/A	Active
Alere Triage®	90008	FDA UDI	Class II	Unknown
SureStep™ Urine Test Drug Screen Strip	DBA-101	FDA UDI	Class II	Active
SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup	DBO-167-022	FDA UDI	Class II	Active
SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)	DTH-101-a-Sgl	FDA UDI	Class II	Active
Clearview®	92405	FDA UDI	Class I	Unknown
Cholestech LDX™	14874	FDA UDI	Class I	Active
Signify®	01P52-25	FDA UDI	Class II	Active
CERTUM COC One Step Cocaine Test Strip	DCO-U101-a-Sgl	FDA UDI	Class II	Active
SureStepTM Urine Drug Test Cassette	DTH-102a	FDA UDI	Class II	Active
SureStepTM Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500	DMD-101-a-Sgl	FDA UDI	Class II	Active

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FDA Recalls (59)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 1, 2024	Z-1702-2024	—	open, classified	There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.
Jun 24, 2022	Z-1508-2022	—	open, classified	Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).
Feb 15, 2019	Z-2475-2019	—	terminated	The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.
Nov 14, 2017	Z-0418-2018	—	completed	The recalled lots have demonstrated unexpected false positive THC results.
Oct 12, 2016	Z-0588-2017	—	terminated	Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.
Aug 2, 2016	Z-2778-2016	—	terminated	Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
Jul 11, 2016	Z-2355-2016	—	terminated	Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Jul 11, 2016	Z-2354-2016	—	terminated	Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Jul 11, 2016	Z-2361-2016	—	terminated	Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Jul 11, 2016	Z-2356-2016	—	terminated	Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Jul 11, 2016	Z-2360-2016	—	terminated	Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Jul 11, 2016	Z-2362-2016	—	terminated	Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Test Strips. This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Jul 11, 2016	Z-2357-2016	—	terminated	Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Jul 11, 2016	Z-2359-2016	—	terminated	Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Jul 11, 2016	Z-2358-2016	—	terminated	Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Jun 22, 2016	Z-2265-2016	—	terminated	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Jun 22, 2016	Z-2270-2016	—	terminated	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Jun 22, 2016	Z-2267-2016	—	terminated	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Jun 22, 2016	Z-2271-2016	—	terminated	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Jun 22, 2016	Z-2268-2016	—	terminated	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Jun 22, 2016	Z-2269-2016	—	terminated	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Jun 22, 2016	Z-2266-2016	—	terminated	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Aug 27, 2015	Z-0122-2016	—	terminated	Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
Dec 5, 2014	Z-0881-2015	—	terminated	In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
Dec 5, 2014	Z-0880-2015	—	terminated	In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
Dec 5, 2014	Z-0882-2015	—	terminated	In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
May 30, 2014	Z-1928-2014	—	terminated	Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4. This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator.
May 2, 2014	Z-1727-2014	—	terminated	Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.
Apr 16, 2014	Z-1546-2014	—	terminated	Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Mar 20, 2014	Z-1540-2014	—	terminated	These lots may not recover within range when tested using certain commercially available controls.
Feb 5, 2014	Z-1214-2014	—	terminated	Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results.
Oct 23, 2013	Z-0379-2014	—	terminated	Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067.
Sep 23, 2013	Z-0053-2014	—	terminated	Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.
Jun 3, 2013	Z-0653-2014	—	terminated	Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk.
Apr 16, 2013	Z-1401-2013	—	terminated	The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) Product Insert contains information for
Mar 6, 2013	Z-1139-2013	—	terminated	The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.
Mar 6, 2013	Z-1178-2013	—	terminated	The Alere Cholestech LDX hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.
Feb 26, 2013	Z-1148-2013	—	terminated	Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Jan 21, 2013	Z-1344-2013	—	terminated	Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.
Oct 22, 2012	Z-0746-2013	—	terminated	Out of range (increased) HDL Cholesterol results.
Oct 22, 2012	Z-0747-2013	—	terminated	Out of range (increased) HDL Cholesterol results.
Jul 12, 2012	Z-2460-2012	—	terminated	Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.
May 22, 2012	Z-1931-2012	—	terminated	Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
May 22, 2012	Z-1928-2012	—	terminated	Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
May 22, 2012	Z-1930-2012	—	terminated	Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
May 22, 2012	Z-1932-2012	—	terminated	Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
May 22, 2012	Z-1929-2012	—	terminated	Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
May 14, 2012	Z-2039-2012	—	terminated	A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen.
Mar 5, 2012	Z-1467-2012	—	terminated	Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP, Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300, Lot W48990. Alere San Diego, Inc. has determined that these lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing.
Mar 5, 2012	Z-1466-2012	—	terminated	Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP, Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300, Lot W48990. Alere San Diego, Inc. has determined that these lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing.
Jan 4, 2012	Z-1130-2012	—	terminated	Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.
Oct 11, 2011	Z-0188-2012	—	terminated	Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus.
Sep 1, 2011	Z-1075-2012	—	terminated	Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry period.
Sep 1, 2011	Z-1074-2012	—	terminated	Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry period.
Jul 1, 2011	Z-0521-2012	—	terminated	The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928.
Jun 10, 2011	Z-2881-2011	—	terminated	Alere is initiating a voluntary recall on the listed lots of MULTI-DRUG 9 PANEL INTEGRATED CUP manufactured by Alere for sole use by Calloway Labs due to a mistake that occurred while processing the order, these products were incorrectly labeled as CLIA Waived, when in fact the devices are classified as Moderately Complex. Therefore these devices are misbranded.
Feb 28, 2011	Z-2661-2011	—	terminated	The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections.
Nov 16, 2010	Z-0964-2012	—	terminated	Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability.
May 28, 2009	Z-0029-2013	—	terminated	Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.