ZYM B Reagent — Class II medical device recall Z-1475-2014
Terminated recall by BioMerieux SA, reported 2014-04-30, distributed nationwide. bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF
| Recall number | Z-1475-2014 |
|---|---|
| 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 | 2014-03-06 |
| Classified | 2014-04-18 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2017-03-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BG, BH, BO, BR, CA, CL, CN, CO, CR, CZ, DE, DZ, EC, EE, EG, ES, FR, GB, GH, GR, GT, HN, HR, HT, HU, ID, IL, IN, IQ, IT, JM, JO, JP, KE, KR, KW, LB, LT, LV, MA, MX, MY, NG, NL, OM, PA, PE, PH, PK, PL, PT, PY, QA, RS, RU, SA, SE, SG, SI, SV, TH, TN, TR, TT, UA, UY, VE, VN, ZA |
| Quantity | 33,853 |
| Model numbers | 70493 |
| Expiration dates | 2014-10-14, 2014-10-24, 2014-10-30, 2014-11-04, 2014-11-26, 2014-12-12 |
Product
ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
Reason for recall
bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB 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-1475-2014. 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.