Reported Oct 8, 2014 · Terminated
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST…
ELITech Clinical Systems SAS
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ELITech Clinical Systems SAS · Zone lndustrielle · SEES, N/A · N/A
Is this the product you have?
ENVOY 500 AST Reagent Kitreference Model/Catalog 55255for Envoy 500
- Intended Use of the ProductEnvoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases
- Lot codes and dates
Lot 4014Expiration date 07/2015Lot 4051Expiration date 09/2015Lot 4074Expiration date 11/2015
- Amount recalled
- 878 kits
Where it was sold
- Nationwide
Why it was recalled
Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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