Reported Feb 10, 2016 · Terminated
API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some…
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?
- API ZYM Bx2 (Ref 70493) Product UsageZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 2 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 3 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 4 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 5 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16 6 Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16 7 Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16 8 Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16 9 Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16 - Amount recalled
- 13,271
Where it was sold
Why it was recalled
Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent.
This product could cause temporary or reversible health problems — stop using it.
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