API ZYM Bx2 — Class II medical device recall Z-0756-2016
Terminated recall by BioMerieux SA, reported 2016-02-10, distributed nationwide. Discrepant identification results related to API identification strips. These discrepant identification result
| Recall number | Z-0756-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, N/A, France |
| Recall initiated | 2016-01-08 |
| Classified | 2016-02-04 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2017-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 13,271 |
| Lot numbers | 1003765610, 1003772410, 1003772470, 1003787970, 1003790030, 1004077210, 1004097610, 1004355410, 1004355730 |
| Model numbers | 70493 |
| Expiration dates | 2016-01-12, 2016-01-15, 2016-01-19, 2016-01-29, 2016-02-26, 2016-05-25, 2016-06-02, 2016-09-20 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0756-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.