Data Foundry

Medical device recalls 2015

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 numberZ-1621-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmbioMerieux, Inc., Durham, NC, United States
Recall initiated2015-04-14
Classified2015-05-15
Reported by FDA2015-05-27
Terminated2017-12-13
DistributedGA, GU
Countries outside the USAE, 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
Quantity730 units
Model numbers411402, 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.