Reported Oct 2, 2013 · Terminated
DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by:…
Microgenics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Microgenics Corp · 46360 Fremont Blvd · Fremont, CA · 94538-6406
Is this the product you have?
- DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml
- IVD Mfg byMicrogenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 0055lot number 60053405, Exp 2/29/2016 0056lot number 60053396, Exp 2/29/2016 10014593lot number 60112588, Exp 2/29/2016 l40-20not distributed , lot number 24215M500, Exp 8/13/14. - Amount recalled
- 1473 units in distribution.
Where it was sold
Why it was recalled
Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.
This product could cause temporary or reversible health problems — stop using it.
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