Reported Apr 30, 2014 · Terminated
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized…
BioMerieux SA
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: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile, N/A · N/A
Is this the product you have?
- FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
- Lot codes and dates
Codes - 1002717180Exp. Date 5/30/20141002737220Exp. Date 6/13/20141002778550Exp. Date 8/9/20141002782960Exp. Date 8/15/20141002792840Exp. Date 8/15/20141002834130Exp. Date 8/22/20141002877370Exp. Date 8/22/2014
- Amount recalled
- 33,853
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
This product could cause temporary or reversible health problems — stop using it.
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