FDA Device recall Z-0756-2016
API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical…
- FDA Device
- Class II
- terminated
- Published 2016-02-10
On 2016-02-10 the FDA classified a Class II recall of API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical… by Biomerieux, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0756-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-08 |
| Published | 2016-02-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
Reason
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.
Identifiers
| code_info | Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 10037…Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16 Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16 Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16 Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16 Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0756-2016%22
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