API NIH — Class II medical device recall Z-1477-2014
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-1477-2014 |
|---|---|
| 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 | 10400 |
| Expiration dates | 2014-06-03, 2014-06-18, 2014-09-09, 2014-12-13 |
Product
API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most 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-1477-2014. 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.