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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 3 of 16

Device	Model / Reference	Registries	Class	Status
Creatinine Enzymatic	12-C7548-162	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-B7538-NIT-15	FDA UDI	Class II	Active
POINTE SCIENTIFIC Cholesterol Standard	C7509-STD	FDA UDI	Class I	Active
Pointe Scientific, Inc. Toxoplasma IgM	T8002-96	FDA UDI	Class II	Active
Pointe Scientific, Inc.	HI790-SCS	FDA UDI	N/A	Active
Pointe Ethyl Alcohol Calibrator (100 mg/dL)	60-EA0446-5	FDA UDI	Class II	Active
Pointe Methadone Metabolite (EDDP) Calibrator (100 ng/mL) Cutoff	60-MM0406-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-T7532-1000	FDA UDI	Class I	Active
Alk Phos R2 (w/ssa#)	13-A7516-R2-30	FDA UDI	Class II	Active
POINTE SCIENTIFIC Amylase	12-A7564-120	FDA UDI	Class II	Active
Pointe Scientific Inc.	HA916-492	FDA UDI	Class II	Active
Pointe Scientific, Inc. Glyco Standard	13-G7540-STD	FDA UDI	Class II	Active
POINTE SCIENTIFIC BUN Liquid	B7552-625	FDA UDI	Class II	Active
Pointe Scientific, Inc.	T7531-STD	FDA UDI	Class I	Active
Pointe Scientific, Inc. autoLDL Cholesterol	OL974-480	FDA UDI	Class I	Active
Pointe Scientific, Inc.	H7541-40	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-B7576-120	FDA UDI	Class II	Active
Pointe Scientific, Inc. Total Protein	T7528-1L	FDA UDI	N/A	Active
Pointe Propoxyphene (PPX) Reagent Set	60-PP0240-1L	FDA UDI	Class II	Active
Pointe Oxycodone Control (225 ng/mL)	60-OX0490-5	FDA UDI	Class I	Active
Pointe Cannabinoids (THC) Calibrator (150 ng/mL)	60-TH0156-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	T1001-96	FDA UDI	Class II	Active
Pointe Ecstasy (MDMA) Calibrator (750 ng/mL) Intermediate	60-EC0328-5	FDA UDI	Class II	Active
Pointe Oxycodone Calibrator (100 ng/mL)	60-OX0486-5	FDA UDI	Class II	Active
Pointe Scientific	HB952-654	FDA UDI	Class II	Active
Phosphorus	12-P7516-160	FDA UDI	Class I	Active
POINTE SCIENTIFIC CK-MB Controls	C7562-12	FDA UDI	Class I	Active
ALT R1 (w/ssa#)	13-A7526-R1-120	FDA UDI	Class I	Active
Pointe Scientific, Inc. Magnesium	HM929-1000	FDA UDI	Class I	Active
Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate	60-MM0408-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	H7541-CAL	FDA UDI	Class II	Active
Pointe Propoxyphene (PPX) Calibrator (600 ng/mL) Intermediate	60-PP0248-5	FDA UDI	Class II	Active
Pointe Ecstasy (MDMA) Reagent Set	60-EC0320-100	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-L7572-R2-125	FDA UDI	Class II	Active
Pointe Meprobamate Calibrator (50 ng/mL) Low	60-MB0744-5	FDA UDI	Class II	Active
Pointe AST on the BS480 Analyzer	14-A7561-375	FDA UDI	Class II	Active
Pointe Scientific, Inc.	H7512-STD	FDA UDI	Class I	Active
POINTE SCIENTIFIC Albumin	A7502-120	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-C7513-STD	FDA UDI	Class II	Active
POINTE SCIENTIFIC CRP-High Sensitivity	C7568-100	FDA UDI	Class II	Active
Pointe Scientific, Inc. CK	HC922-300	FDA UDI	Class II	Active
Pointe Opiates 300 Calibrator (Morphine 150 ng/mL)	60-OP0044-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	A7503-100	FDA UDI	Class II	Active
Pointe Creatine Kinase Reagent	16-C7522-225	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-A7561-R2-30	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-C7509-STD	FDA UDI	Class I	Active
Pointe Meprobamate Calibrator (400 ng/mL) High	60-MB0750-5	FDA UDI	Class II	Active
Pointe Scientific, Inc.	13-C7510-500	FDA UDI	Class I	Active
Pointe Opiates 300 Calibrator (Morphine 1000 ng/mL)	60-OP0050-5	FDA UDI	Class II	Active
Pointe Lactic Acid Reagent	16-L7596-400	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.