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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 5 of 16

Device	Model / Reference	Registries	Class	Status
Pointe Scientific, Inc.	13-C7529-120	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-T7532-500	FDA UDI	Class I	Active
Pointe Scientific, Inc.	L7574-40	FDA UDI	Class I	Active
Pointe Scientific, Inc.	HC939-1340	FDA UDI	Class II	Active
Pointe Scientific, Inc. Bilirubin, Direct	HB936-1250	FDA UDI	Class II	Active
Pointe Scientific, Inc.	F1027-96	FDA UDI	Class II	Active
Pointe autoLDL Cholesterol Reagent	14-L7574-320	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-L7572-R2-30	FDA UDI	Class II	Active
POINTE SCIENTIFIC Alkaline Phosphatase (Liquid)	A7516-450	FDA UDI	Class II	Active
Pointe Opiates 2000 Level 1 Control (Morphine 1500 ng/mL)	60-OP0674-5	FDA UDI	Class I	Active
Pointe Scientific, Inc.	G7571-625	FDA UDI	Class I	Active
Pointe Opiates 2000 Calibrator (Morphine 4000 ng/mL)	60-OP0668-5	FDA UDI	Class II	Active
Pointe Multi-Analyte Set D Urine DAU Low Calibrator	60-MA1744-15	FDA UDI	Class II	Active
Pointe Phencyclidine (PCP) Level 1 Control (18 ng/mL)	60-PC0034-5	FDA UDI	Class I	Active
Pointe Methadone Metabolite (EDDP) Control (375 ng/mL) Level 2	60-MM0396-5	FDA UDI	Class I	Active
POINTE SCIENTIFIC Bilirubin, Direct	B7538-120	FDA UDI	Class II	Active
Pointe Norbuprenorphine Intermediate Calibrator #2 (40 ng/mL)	60-NB0556-5	FDA UDI	Class II	Active
Pointe Scientific, Inc. Direct Bilirubin	OB936-114	FDA UDI	Class II	Active
Pointe Scientific, Inc. Phosphorus	P7516-500	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-T7528-500	FDA UDI	Class II	Active
Pointe Scientfic, Inc.	HB936-294	FDA UDI	Class II	Active
Pointe Scientific, Inc. Iron	OI904-481	FDA UDI	Class I	Active
Pointe Scientific, Inc.	13-B7538-120	FDA UDI	Class II	Active
Pointe Scientific autoLDL Cholesterol	HL974-480	FDA UDI	Class I	Active
Pointe Opiates 2000 Calibrator (Morphine 6000 ng/mL)	60-OP0670-5	FDA UDI	Class II	Active
Direct Bilirubin	12-HB936-156	FDA UDI	Class II	Active
Pointe Scientific, Inc. Creatinine Enzymatic	HC948-480	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-A7526-R2-30	FDA UDI	Class I	Active
Pointe Oxycodone Calibrator (800 ng/mL)	60-OX0498-5	FDA UDI	Class II	Active
Pointe GGT Reagent	16-HG959-236	FDA UDI	Class I	Active
POINTE SCIENTIFIC Calcium Arsenazo	C7529-1L	FDA UDI	Class II	Active
Pointe Scientific, Inc.	H7546-CTL	FDA UDI	Class II	Active
Pointe Scientific, Inc.	H7575-57	FDA UDI	Class II	Active
Pointe Cocaine Calibrator (BE 150 ng/mL)	60-CC0064-5	FDA UDI	Class II	Active
Pointe Phencyclidine (PCP) Level 2 Control (32 ng/mL)	60-PC0036-5	FDA UDI	Class I	Active
autoHDL	12-H7545-162	FDA UDI	Class I	Active
Pointe Multi-Analyte Set C Urine DAU High Calibrator	60-MA1710-15	FDA UDI	Class II	Active
Pointe Scientific, Inc.	H7541-LYS	FDA UDI	N/A	Active
Pointe Scientific, Inc. Lipase-Color	L7503-40	FDA UDI	Class I	Active
Pointe Scientific, Inc.	H7506-6	FDA UDI	Class II	Active
Pointe Cholesterol Reagent	16-C7510-520	FDA UDI	Class I	Active
Pointe Scientific, Inc. Glucose	OG917-396	FDA UDI	Class II	Active
Pointe Hydrocodone 300 Calibrator (500 ng/mL)	60-HY0788-5	FDA UDI	Class II	Active
Pointe Lp(a) Reagent	14-L7597-216	FDA UDI	Class II	Active
Pointe Total Bilirubin Reagent	16-HB979-395	FDA UDI	Class II	Active
Pointe Scientific Bun	12-B7552-150	FDA UDI	Class II	Active
Pointe Cocaine Level 1 Control (BE 225 ng/mL)	60-CC0074-5	FDA UDI	Class I	Active
Pointe Scientific, Inc.	CM1105-96	FDA UDI	Class II	Active
Pointe Scientific, Inc.	HB952-1020	FDA UDI	Class II	Active
POINTE SCIENTIFIC BUN (Berthelot)	B7551-120	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.