API NH — Class II medical device recall Z-0843-2014
Terminated recall by Biomerieux France Chemin De L'Or, reported 2014-02-05, distributed nationwide. bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false
| Recall number | Z-0843-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux France Chemin De L'Or, Marcy L'Etoile, France |
| Recall initiated | 2013-11-08 |
| Classified | 2014-01-27 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2017-11-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, EC, EE, EG, ES, FR, GB, GR, GT, HN, HU, ID, IL, IN, IQ, IT, JM, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NG, NL, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SK, SV, TH, TN, TR, TT, UA, UY, VE, VN, ZA |
| Quantity | 39,439 kits |
| Lot numbers | 1001896203, 1001957530, 1001957531, 1002112170, 1002112171, 1002112172, 1002112173, 1002171110, 1002171111, 1002279350, 1002279351, 1002279352, 1002340500, 1002340501, 1002340502, 1002340503, 1002412550, 1002412551, 1002455912, 1002485910, 1002485911 |
| Model numbers | 10400 |
Product
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.
Reason for recall
bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using 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-0843-2014. 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.