92 results
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81ms
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Sources: EU EUDAMED, US FDA
INVIRO MEDICAL
FDA Adverse Event
Malfunction
·INVIRO MEDICAL DEVICES INC.·Product code FMF·October 15, 2007
InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.
FDA Recall
Terminated
·Inviro Medical Devices, Inc·Product code MEG·May 10, 2010
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·July 10, 2024
Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.
FDA Recall
Terminated
·Abaxis Inc·Product code JFY·November 16, 2009
Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code KNK·December 1, 2009
Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code KNK·December 1, 2009
Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.
FDA Recall
Terminated
·Whatman, Inc.·Product code JKA·May 19, 2009
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CIG·February 2, 2009
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CKA·December 14, 2007
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CKA·December 14, 2007
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CKA·December 14, 2007
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CKA·December 14, 2007
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 305 ml, Catalog no. HA 726-305, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CKA·December 14, 2007
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CKA·December 14, 2007
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CKA·December 14, 2007
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CKA·December 14, 2007
Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·February 7, 2008
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·February 7, 2008