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Pointe Scientific, Inc.

81 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-15 recall (Z-2773-2015)Pointe Scientific, Inc.2015-09-16
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic recall (Z-2764-2015)Pointe Scientific, Inc.2015-09-14
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Le recall (Z-2487-2015)Pointe Scientific, Inc.2015-08-31
Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientif recall (Z-1041-2010)Pointe Scientific, Inc.2010-03-10
Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Point recall (Z-1042-2010)Pointe Scientific, Inc.2010-03-10
Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Point recall (Z-1043-2010)Pointe Scientific, Inc.2010-03-10
Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C recall (Z-1035-2010)Pointe Scientific, Inc.2010-03-09
Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7 recall (Z-1036-2010)Pointe Scientific, Inc.2010-03-09
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catal recall (Z-1014-2010)Pointe Scientific, Inc.2010-03-05
Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron recall (Z-0899-2010)Pointe Scientific, Inc.2010-03-02
Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron recall (Z-0900-2010)Pointe Scientific, Inc.2010-03-02
Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of seru recall (Z-0901-2010)Pointe Scientific, Inc.2010-03-02
Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of s recall (Z-0902-2010)Pointe Scientific, Inc.2010-03-02
Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of s recall (Z-0903-2010)Pointe Scientific, Inc.2010-03-02
Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI., Catalog recall (Z-0904-2010)Pointe Scientific, Inc.2010-03-02
Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog recall (Z-0905-2010)Pointe Scientific, Inc.2010-03-02
Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron, Poi recall (Z-0906-2010)Pointe Scientific, Inc.2010-03-02
Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Cat recall (Z-0912-2010)Pointe Scientific, Inc.2010-03-02
Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; recall (Z-0913-2010)Pointe Scientific, Inc.2010-03-02
Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, P recall (Z-0859-2010)Pointe Scientific, Inc.2010-02-25
Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H751 recall (Z-0860-2010)Pointe Scientific, Inc.2010-02-25
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; C recall (Z-0104-2010)Pointe Scientific, Inc.2009-11-04
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton recall (Z-1200-2009)Pointe Scientific, Inc.2009-04-27
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton recall (Z-1201-2009)Pointe Scientific, Inc.2009-04-27
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The de recall (Z-1202-2009)Pointe Scientific, Inc.2009-04-17
Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe recall (Z-1091-2009)Pointe Scientific, Inc.2009-03-12
Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton, MI; recall (Z-0219-2009)Pointe Scientific, Inc.2008-10-31
Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; recall (Z-0220-2009)Pointe Scientific, Inc.2008-10-31
Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Cata recall (Z-0221-2009)Pointe Scientific, Inc.2008-10-31
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; C recall (Z-0222-2009)Pointe Scientific, Inc.2008-10-31
Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry) recall (Z-0223-2009)Pointe Scientific, Inc.2008-10-31
Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry) recall (Z-0224-2009)Pointe Scientific, Inc.2008-10-31
Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 recall (Z-0171-2009)Pointe Scientific, Inc.2008-10-22
AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. recall (Z-0172-2009)Pointe Scientific, Inc.2008-10-22
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alan recall (Z-1110-2008)Pointe Scientific, Inc.2008-05-22
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alan recall (Z-1111-2008)Pointe Scientific, Inc.2008-05-22
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alan recall (Z-1112-2008)Pointe Scientific, Inc.2008-05-22
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alan recall (Z-1113-2008)Pointe Scientific, Inc.2008-05-22
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alan recall (Z-1114-2008)Pointe Scientific, Inc.2008-05-22
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alan recall (Z-1115-2008)Pointe Scientific, Inc.2008-05-22
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alan recall (Z-1116-2008)Pointe Scientific, Inc.2008-05-22
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alan recall (Z-1117-2008)Pointe Scientific, Inc.2008-05-22
Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450, A7516-625, HA9 recall (Z-1353-2008)Pointe Scientific, Inc.2008-03-27
Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro diagnostic; recall (Z-1354-2008)Pointe Scientific, Inc.2008-03-27
Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scient recall (Z-1355-2008)Pointe Scientific, Inc.2008-03-27
Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe Sc recall (Z-1356-2008)Pointe Scientific, Inc.2008-03-27
Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe Sc recall (Z-1357-2008)Pointe Scientific, Inc.2008-03-27
Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120 recall (Z-1358-2008)Pointe Scientific, Inc.2008-03-27
Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125 recall (Z-1359-2008)Pointe Scientific, Inc.2008-03-27
Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; f recall (Z-1360-2008)Pointe Scientific, Inc.2008-03-27
Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood recall (Z-1543-06)Pointe Scientific, Inc.2006-09-30
Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum, Imported recall (Z-1544-06)Pointe Scientific, Inc.2006-09-30
Alcohol Standard, 100 mg/dl, Pointe Scientific Inc., Canton, MI; Catalog # A7504-STD. recall (Z-1545-06)Pointe Scientific, Inc.2006-09-30
Alcohol Control sold by Pointe Scientific; Catalog # 7-A7504-CTL. recall (Z-1546-06)Pointe Scientific, Inc.2006-09-30
Alcohol Control, Level 1 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L1. recall (Z-1547-06)Pointe Scientific, Inc.2006-09-30
Alcohol Control, Level 2 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L2. recall (Z-1548-06)Pointe Scientific, Inc.2006-09-30
Alcohol Standard sold by Pointe Scientific; Catalog # 7-A7504-STD. recall (Z-1549-06)Pointe Scientific, Inc.2006-09-30
Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog recall (Z-1454-06)Pointe Scientific, Inc.2006-08-30
AutoHDL Cholesterol Reagent Set for the quantitative determination of high density lipopro recall (Z-1455-06)Pointe Scientific, Inc.2006-08-30
AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of h recall (Z-1456-06)Pointe Scientific, Inc.2006-08-30
AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of h recall (Z-1457-06)Pointe Scientific, Inc.2006-08-30
Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L . recall (Z-1458-06)Pointe Scientific, Inc.2006-08-30
Auto HDL Cholesterol reagent in bottles of 320 ml and 1000 ml, sold by Pointe Scientific; recall (Z-1459-06)Pointe Scientific, Inc.2006-08-30
Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline pho recall (Z-1388-06)Pointe Scientific, Inc.2006-08-10
Liquid Alkaline Phosphatase (R1) Reagent Set for the quantitative determination of alkalin recall (Z-1389-06)Pointe Scientific, Inc.2006-08-10
Liquid Alkaline Phosphatase (R2) Reagent Set for the quantitative determination of alkalin recall (Z-1390-06)Pointe Scientific, Inc.2006-08-10
Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell recall (Z-1391-06)Pointe Scientific, Inc.2006-08-10
Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldw recall (Z-1392-06)Pointe Scientific, Inc.2006-08-10
Liquid Alk Phos Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-L. In vitro diagno recall (Z-1393-06)Pointe Scientific, Inc.2006-08-10
Liquid Alk Phos R1 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R1. In vitro di recall (Z-1394-06)Pointe Scientific, Inc.2006-08-10
Liquid Alk Phos R2 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R2. In vitro di recall (Z-1395-06)Pointe Scientific, Inc.2006-08-10
Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml, 120 ml, 2 L and 50 recall (Z-1396-06)Pointe Scientific, Inc.2006-08-10
Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and recall (Z-1397-06)Pointe Scientific, Inc.2006-08-10
Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination recall (Z-1326-06)Pointe Scientific, Inc.2006-08-03
Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative determination recall (Z-1327-06)Pointe Scientific, Inc.2006-08-03
Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the quantitative determination of recall (Z-1328-06)Pointe Scientific, Inc.2006-08-03
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative determination of recall (Z-1329-06)Pointe Scientific, Inc.2006-08-03
Glucose Hex reagent, sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L recall (Z-1330-06)Pointe Scientific, Inc.2006-08-03
Glucose HEX reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L. recall (Z-1331-06)Pointe Scientific, Inc.2006-08-03
Glucose HEX R1 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920 recall (Z-1332-06)Pointe Scientific, Inc.2006-08-03
Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920 recall (Z-1333-06)Pointe Scientific, Inc.2006-08-03

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Every clearance here is in the API, with alerts when new ones post.