API Listeria — Class II medical device recall Z-0842-2014
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-0842-2014 |
|---|---|
| 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 | 1001915090, 1001915091, 1001915092, 1001932340, 1001998120, 1002129350, 1002210010, 1002210011, 1002287930, 1002287931, 1002350760, 1002390940, 1002390941, 1002518070, 1002518071, 1002518072 |
| Model numbers | 10300 |
Product
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
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-0842-2014. 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.