Reported Feb 5, 2014 · Terminated
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses…
Biomerieux France Chemin De L'Or
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 France Chemin De L'Or · Chemin De L'Orme · Marcy L'Etoile · N/A
Is this the product you have?
- API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
- Lot codes and dates
- Lot numbers
100221001010022100111002287930100228793110023507601002390940100239094110025180701002518071100251807210019150901001915091100191509210019323401001998120 and 1002129350
- Lot numbers
- Amount recalled
- 39439 kits (includes ZYM B reagents, API Listeria * API NH kits)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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