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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 6 of 16

Device	Model / Reference	Registries	Class	Status
Pointe Scientific, Inc.	I7506-500	FDA UDI	Class I	Active
Pointe Magnesium Reagent	16-HM929-250	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-C7529-500	FDA UDI	Class II	Active
Pointe Amphetamines 1000 Calibrator (MAMP 2000 ng/mL)	60-AM0090-5	FDA UDI	Class II	Active
Pointe Carbon Dioxide Reagent	16-C7502-180	FDA UDI	Class II	Active
Pointe Multi-Analyte Set C Urine DAU Low Calibrator	60-MA1704-15	FDA UDI	Class II	Active
Pointe Scientific, Inc.	L7596-50	FDA UDI	Class II	Active
Pointe Fentanyl (Qualitative) Reagent Set	60-FN0620-1L	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-G7571-R2-125	FDA UDI	N/A	Active
Pointe Scientific, Inc.	I7517-150	FDA UDI	Class I	Active
POINTE SCIENTIFIC Cholesterol (Liquid)	C7510-500	FDA UDI	Class I	Active
Pointe Scientific Ammonia	A7553-34	FDA UDI	Class I	Active
POINTE SCIENTIFIC Alkaline Phosphatase (Liquid)	A7516-625	FDA UDI	Class II	Active
Pointe Methadone Level 1 Control (225 ng/mL)	60-ME0234-5	FDA UDI	Class I	Active
POINTE SCIENTIFIC CRP Control Set	C7568-CTL	FDA UDI	Class II	Active
Pointe Scientific	HB936-120	FDA UDI	Class II	Active
Pointe Scientific, Inc.	I7504-60	FDA UDI	Class I	Active
Pointe Benzodiazepine Calibrator (Oxazepam 1000 ng/mL)	60-BZ0270-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	C7548-120	FDA UDI	Class II	Active
Pointe Multi-Analyte Set C Urine DAU Intermediate Calibrator	60-MA1708-15	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-T7528-STD	FDA UDI	Class II	Active
Crp	12-C7568-40	FDA UDI	Class II	Active
POINTE SCIENTIFIC Bilirubin, Total	B7576-1L	FDA UDI	Class II	Active
Pointe Scientific, Inc.	G7540-40	FDA UDI	Class II	Active
Pointe Scientific, Inc. Magnesium	HM929-120	FDA UDI	N/A	Active
Pointe Cocaine Metabolite 150 Calibrator (BE 150 ng/mL)	60-CC0686-5	FDA UDI	Class II	Active
Pointe Amphetamines 1000 Calibrator (MAMP 500 ng/mL)	60-AM0084-5	FDA UDI	Class II	Active
POINTE SCIENTIFIC Calcium (2 part)	C7503-480	FDA UDI	Class II	Active
Pointe Oxycodone Control (375 ng/mL)	60-OX0494-5	FDA UDI	Class I	Active
Pointe Scientfic Inc.	HA926-610	FDA UDI	Class I	Active
Pointe Scientific, Inc.	HT932-1000	FDA UDI	Class I	Active
Pointe Scientific, Inc. Microalbumin Calibrator	M7562-CAL	FDA UDI	Class II	Active
Pointe Scientific Ast	12-A7561-100	FDA UDI	Class II	Active
Pointe Hydrocodone 300 Reagent Set	60-HY0780-1L	FDA UDI	N/A	Active
HbA1c	12-H7546-40	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-P7516-500	FDA UDI	Class I	Active
Pointe Scientific, Inc. autoHDL Cholesterol	OH945-480	FDA UDI	Class I	Active
Pointe Scientific, Inc. Triglycerides	HT932-780	FDA UDI	Class I	Active
Pointe 6-Acetylmorphine Calibrator (10 ng/mL) Cutoff	60-AC0586-5	FDA UDI	Class II	Active
Ck	12-C7522-100	FDA UDI	Class II	Active
Pointe Scientific, Inc.	U7580-STD	FDA UDI	Class I	Active
POINTE SCIENTIFIC CK (Liquid)	C7522-625	FDA UDI	Class II	Active
Pointe Cannabinoids (THC) Control (31.25 ng/mL)	60-TH0148-5	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-C7539-R1-1000	FDA UDI	Class II	Active
Pointe Scientific, Inc.	HH945-240	FDA UDI	Class I	Active
Pointe Scientific, Inc.	P1035-96	FDA UDI	Class II	Active
Pointe Scientific, Inc. Gyco Lyse	13-G7540-LYS-30	FDA UDI	Class II	Active
Pointe Magnesium Reagent	14-HM929-240	FDA UDI	Class I	Active
Pointe Phencyclidine (PCP) Calibrator (12.5 ng/mL)	60-PC0024-5	FDA UDI	Class II	Active
Pointe Scientific, Inc. CK	HC722-1200	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.