Reported Feb 5, 2014 · Terminated
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related…
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 NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.
- Lot codes and dates
- Lot numbers
100189620310019575301001957531100211217010021121711002112172100227935110023405001002112173100217111110021711101002279350100227935210023405011002340502100234050310024125501002412551100248591010024859111002455912
- 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.
Want the full recall guide?
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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