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POINTE SCIENTIFIC, INC.

Last updated May 24, 2026

Information

Country: US
Address: —
Website: medtestdx.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-445-9853
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 045623154

Catalogue (769)

Page 1 of 16

Device	Model / Reference	Registries	Class	Status
POINTE SCIENTIFIC Creatinine Standard	C7513-STD	FDA UDI	Class II	Active
Pointe Scientific, Inc.	H7504-120	FDA UDI	Class II	Active
Pointe Scientific, Inc.	HI990-DIL	FDA UDI	N/A	Active
Pointe Scientific, Inc. Triglycerides	HT732-2000	FDA UDI	Class I	Active
Pointe Direct TIBC Reagent	14-I7517-384	FDA UDI	Class I	Active
Pointe Lactate Dehydrogenase Reagent	16-HL956-236	FDA UDI	Class II	Active
Pointe Uric Acid Reagent	14-U7581-160	FDA UDI	Class I	Active
Pointe Scientific, Inc. ALT	OA926-487	FDA UDI	Class I	Active
Pointe Methadone Metabolite (EDDP) Reagent Set	60-MM0380-100	FDA UDI	Class II	Active
Pointe Cannabinoids (THC) Control (18.75 ng/mL)	60-TH0012-5	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-C7539-R1-500	FDA UDI	Class II	Active
Pointe Scientific, Inc.	F1029-96	FDA UDI	Class I	Active
Magnesium	12-HM729-160	FDA UDI	Class I	Active
Pointe Scientific, Inc.	HI717-120	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-A7561-R2-125	FDA UDI	Class II	Active
Point Scientific	T7532-500	FDA UDI	Class I	Active
POINTE SCIENTIFIC Albumin Standard	A7502-STD	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-C7503-COL-120	FDA UDI	Class II	Active
Pointe Multi-Analyte E DAU Level 1 Control	60-MA1794-15	FDA UDI	Class I	Active
Pointe 6-Acetylmorphine Calibrator (0 ng/mL) Negative	60-AC0598-5	FDA UDI	Class II	Active
Pointe Methadone Reagent Set	60-ME0220-1L	FDA UDI	Class II	Active
Pointe Methadone Metabolite (EDDP) Calibrator (1000 ng/mL) High	60-MM0390-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-U7581-500	FDA UDI	Class I	Active
Pointe Scientific	HA961-610	FDA UDI	Class II	Active
Pointe AST Reagent	16-A7561-420	FDA UDI	Class II	Active
POINTE SCIENTIFIC Chemistry Control, Level 1	C7590-50	FDA UDI	Class I	Active
Pointe Scientific, Inc.	H7541-120	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-C7522-R1-120	FDA UDI	Class II	Active
Pointe Scientific Ck-Mb	C7562-150	FDA UDI	Class II	Active
Albumin (w/ssa#)	13-A7502-120	FDA UDI	Class II	Active
Pointe Scientific, Inc. HSV-1 & 2 IgG	T8007-96	FDA UDI	Class II	Active
Pointe Scientific, Inc. Calcium	HC902-3000	FDA UDI	Class II	Active
POINTE SCIENTIFIC Carbon Dioxide Standard	C7504-STD	FDA UDI	Class II	Active
POINTE SCIENTIFIC Carbon Dioxide, Liquid Stable	C7502-120	FDA UDI	Class II	Active
Pointe Norbuprenorphine Level 1 Control (3 ng/mL)	60-NB0544-5	FDA UDI	Class I	Active
Pointe Scientific, Inc. Microprotein Standard	P7582-STD	FDA UDI	Class II	Active
Pointe Norbuprenorphine Low/Cutoff Calibrator (5 ng/mL)	60-NB0546-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-C7510-120	FDA UDI	Class I	Active
Pointe Scientific, Inc.	G7540-2	FDA UDI	Class II	Active
Pointe Oxycodone Reagent Set	60-OX0480-100	FDA UDI	Class II	Active
Pointe ALT for the BS480	14-A7526-375	FDA UDI	Class I	Active
Pointe Cocaine Calibrator (BE 300 ng/mL)	60-CC0066-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	H7546-40	FDA UDI	Class II	Active
Pointe Cocaine Metabolite 150 Calibrator (BE 75 ng/mL)	60-CC0684-5	FDA UDI	Class II	Active
Pointe Opiates 2000 Reagent Set	60-OP0660-1L	FDA UDI	Class II	Active
Pointe 6-Acetylmorphine Calibrator (20 ng/mL) Intermediate	60-AC0588-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	G7540-80	FDA UDI	Class II	Active
Pointe Meprobamate Calibrator (200 ng/mL) Intermediate	60-MB0748-5	FDA UDI	Class II	Active
Pointe Calcium Arsenazo for BS480	14-C7529-360	FDA UDI	Class II	Active
Pointe Homocysteine for BS480	14-H7575-144	FDA UDI	Class II	Active

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FDA Recalls (81)

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
May 19, 2015	Z-2487-2015	—	terminated	A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. For this reason we suggest discontinuing use of the control set.
Mar 13, 2015	Z-2764-2015	—	terminated	Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
Dec 12, 2014	Z-2773-2015	—	terminated	Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
Dec 1, 2009	Z-0912-2010	—	terminated	A process deviation occurred during the production of the R1 component which may affect its performance.
Dec 1, 2009	Z-1035-2010	—	terminated	An additional 10% picric acid was added to the R2 component during production.
Dec 1, 2009	Z-0913-2010	—	terminated	A process deviation occurred during the production of the R1 component which may affect its performance.
Dec 1, 2009	Z-1036-2010	—	terminated	An additional 10% picric acid was added to the R2 component during production.
Nov 16, 2009	Z-0899-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0904-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0900-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0901-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0905-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0906-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0903-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0902-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 10, 2009	Z-0860-2010	—	terminated	The firm initiated the recall due to the presence of visible contamination of the product.
Nov 10, 2009	Z-1042-2010	—	terminated	Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Nov 10, 2009	Z-0859-2010	—	terminated	The firm initiated the recall due to the presence of visible contamination of the product.
Nov 10, 2009	Z-1043-2010	—	terminated	Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Nov 10, 2009	Z-1041-2010	—	terminated	Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Oct 19, 2009	Z-0104-2010	—	terminated	There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.
Jul 29, 2009	Z-1014-2010	—	terminated	R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.
Feb 2, 2009	Z-1202-2009	—	terminated	The product performance fails due to precipitation of the R2 component.
Jan 29, 2009	Z-1200-2009	—	terminated	The R1 reagent has microbial contamination.
Jan 29, 2009	Z-1201-2009	—	terminated	The R1 reagent has microbial contamination.
Nov 3, 2008	Z-1091-2009	—	terminated	The product is unable to maintain the specification for linearity through the shelf life of the product.
Sep 10, 2008	Z-0219-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0220-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0224-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0223-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0221-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0222-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Aug 25, 2008	Z-0172-2009	—	terminated	The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
Aug 25, 2008	Z-0171-2009	—	terminated	The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
Feb 7, 2008	Z-1360-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1356-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1354-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1353-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1357-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1355-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1359-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1358-2008	—	terminated	May be contaminated with microorganisms.
Dec 14, 2007	Z-1116-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1117-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1111-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1113-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1112-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1110-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1114-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1115-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Jun 12, 2006	Z-1454-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1455-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1458-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1459-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1456-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1457-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 9, 2006	Z-1392-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1544-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1395-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1397-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1393-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1547-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1391-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1548-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1388-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1396-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1549-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1394-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1545-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1389-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1546-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1543-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1390-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 7, 2006	Z-1328-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1330-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1326-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1329-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1333-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1327-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1332-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1331-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.