MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3 — Class II medical device recall Z-1621-2015
Terminated recall by bioMerieux, Inc., reported 2015-05-27, distributed in GA, GU. The MYLA¿ server could slow down due to the volume (weight) of the data to manage and it could also stop pro
| Recall number | Z-1621-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2015-04-14 |
| Classified | 2015-05-15 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2017-12-13 |
| Distributed | GA, GU |
| Countries outside the US | AE, AR, AT, AU, BD, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, DZ, EC, EE, EG, ES, FR, GR, GT, HN, HU, ID, IL, IN, IQ, IR, IT, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NG, NL, OM, PA, PE, PH, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SK, SV, TH, TN, TR, UA, VE, VN, ZA |
| Quantity | 730 units |
| Model numbers | 411402, 415603 |
Product
MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 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
The MYLA¿ server could slow down due to the volume (weight) of the data to manage and it could also stop processing, impacting the server start-up phase. The problem occurs in high volume settings. The MYLA server slows down and will stop processing completely if any task requires more than 5 minutes to complete. The server then fails to reboot and requires service, provided remotely or on-site
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-1621-2015. 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.