🔍 RecallPedia

All Recalls

95,094 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,647
Consumer Products

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Biomerieux

🏥 Medical Devices Class I - Dangerous

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Feb 24, 2016 Diagnostic Equipment View Details →

Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

St Jude Medical

🏥 Medical Devices Class I - Dangerous

St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.

Mar 31, 2016 Implants & Prosthetics Nationwide View Details →

Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.

Feb 16, 2016 Diagnostic Equipment Nationwide View Details →

Dimension Assays: Triglycerides (TGL)

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Mar 17, 2016 Other Medical Devices Nationwide View Details →

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Mar 17, 2016 Other Medical Devices Nationwide View Details →

Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.

Feb 9, 2016 Diagnostic Equipment View Details →