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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 4 of 16

Device	Model / Reference	Registries	Class	Status
Pointe Alkaline Phosphatase on the BS480	14-A7516-225	FDA UDI	Class II	Active
Pointe Scientific, Inc.	HP916-1200	FDA UDI	Class I	Active
POINTE SCIENTIFIC Fructosamine Calibrator	F7546-CAL	FDA UDI	Class II	Active
POINTE SCIENTIFIC ALT (SGPT) Liquid	A7526-450	FDA UDI	Class I	Active
POINTE SCIENTIFIC AST (SGOT) Liquid	A7561-450	FDA UDI	Class II	Active
Total Bilirubin	12-HB979-192	FDA UDI	Class II	Active
Pointe BUN on BS480	14-B7552-600	FDA UDI	Class II	Active
Pointe Methadone Calibrator (1000 ng/mL)	60-ME0230-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	I7504-400	FDA UDI	Class I	Active
Pointe Scientific, Inc.	HI790-DET	FDA UDI	N/A	Active
Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL)	60-AM0204-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	HI990-REF	FDA UDI	Class II	Active
Pointe Benzodiazepine Reagent Set	60-BZ0260-100	FDA UDI	Class II	Active
Pointe autoLDL Cholesterol Reagent	16-L7574-400	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-B7552-R1-120	FDA UDI	Class II	Active
Pointe Cannabinoids (THC) Calibrator (100 ng/mL)	60-TH0154-5	FDA UDI	Class II	Active
Pointe Amylase Reagent	16-HA965-223	FDA UDI	Class II	Active
Pointe Ecstasy (MDMA) Calibrator (500 ng/mL) Cutoff	60-EC0326-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	G7583-LYS	FDA UDI	N/A	Active
POINTE SCIENTIFIC AST (SGOT) Liquid	A7561-625	FDA UDI	N/A	Active
Pointe Scientifc, Inc.	13-T7531-STD	FDA UDI	Class I	Active
Pointe Cannabinoids (THC) Calibrator (25 ng/mL)	60-TH0146-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	G7540-STD	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-L7572-R1-500	FDA UDI	Class II	Active
Pointe Scientific, Inc.	HP782-400	FDA UDI	Class II	Active
Pointe Scientific, Inc.	HD990-840	FDA UDI	N/A	Active
Pointe Scientific	HB999-804	FDA UDI	N/A	Active
POINTE SCIENTIFIC Calcium (2 part)	C7503-120	FDA UDI	Class II	Active
Pointe Cocaine Metabolite Reagent Set	60-CC0060-1L	FDA UDI	Class II	Active
Pointe Opiates 300 Reagent Set	60-OP0040-1L	FDA UDI	Class II	Active
Pointe Scientific, Inc. BUN	OB952-482	FDA UDI	Class II	Active
Pointe Hydrocodone 300 Calibrator (150 ng/mL)	60-HY0784-5	FDA UDI	Class II	Active
Pointe Total Protein Reagent	14-T7528-480	FDA UDI	Class II	Active
Pointe Cannabinoids (THC) Calibrator (12.5 ng/mL)	60-TH0144-5	FDA UDI	Class II	Active
Pointe Amphetamines 1000 Level 2 Control (MAMP 1250 ng/mL)	60-AM0096-5	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-C7506-DIL-55	FDA UDI	Class II	Active
Pointe Scientific, Inc. CMV IgG	T8005-96	FDA UDI	Class II	Active
Creatinine	12-C7539-98	FDA UDI	Class II	Active
Pointe Scientific, Inc.	H7587-58	FDA UDI	Class I	Active
Pointe Scientific, Inc.	HC702-200	FDA UDI	Class II	Active
POINTE SCIENTIFIC Ammonia Standard 5	A7553-STD500	FDA UDI	Class I	Active
Pointe Scientific, Inc. Magnesium	OM929-300	FDA UDI	Class I	Active
Pointe Hydrocodone 100 Calibrator (50 ng/mL)	60-HY0764-5	FDA UDI	Class II	Active
Calcium	12-C7529-120	FDA UDI	Class II	Active
Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator	60-MA1746-15	FDA UDI	Class II	Active
Pointe Opiates 300 Calibrator (Morphine 600 ng/mL)	60-OP0048-5	FDA UDI	Class II	Active
Pointe Barbiturate Calibrator/Control (Secobarbital 100 ng/mL)	60-BA0284-5	FDA UDI	Class II	Active
Pointe Carisporodol Metabolite (SOMA) Reagent Set	60-CM0740-100	FDA UDI	Class II	Active
Pointe Scientific, Inc. Phosphorus	P7516-120	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-G7571-R1-500	FDA UDI	N/A	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.