MYLA CLINIC PATCH 3 — Class II medical device recall Z-0427-2016
Terminated recall by bioMerieux, Inc., reported 2015-12-23, distributed nationwide. MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to l
| Recall number | Z-0427-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2015-11-03 |
| Classified | 2015-12-16 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2017-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, 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, JP, KE, KR, KW, LB, LT, LV, MY, NG, NL, PH, PL, PT, QA, RS, RU, SA, SE, SG, SK, SV, TN, TR, UA, VN, ZA |
| Quantity | 626 systems |
| Reason classes | software |
| Model numbers | 416192 |
Product
MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
Reason for recall
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
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-0427-2016. 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.