ETEST XM256 — Class II medical device recall Z-1226-2017
Terminated recall by BioMerieux SA, reported 2017-03-01, distributed in AR, AZ, CA, CT, DC, DE, FL, GA…. Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result w
| Recall number | Z-1226-2017 |
|---|---|
| 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 | 2017-01-18 |
| Classified | 2017-02-21 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2020-01-30 |
| Distributed | AR, AZ, CA, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV |
| Countries outside the US | AE, AT, AU, BR, CA, CH, CL, CR, CZ, DE, DZ, EC, EE, ES, FR, GB, GR, HK, HR, IE, IL, IN, IT, JO, JP, KR, KW, LB, LT, LU, MY, NG, NL, NO, OM, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, UY, VN |
| Quantity | 7,160 units |
| Model numbers | 1002884720, 1002884980, 1002885010, 1003028270, 1003028290, 1003075500, 1003075540, 1003075850, 1003383650, 1003385930, 1003396150, 1004018820, 1004019050, 1004022170, 1004497810, 1004497830, 1004498100, 1004501930, 1005161160, 1005161470, 1005161480, 103396550, 412304, 412305, 506918 and 1 more |
Product
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria
Reason for recall
Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.
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-1226-2017. 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.