Class II — bioMerieux, Inc.
| Recalling firm | BIOMERIEUX SA |
|---|---|
| Registered facility | View this company's 16 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | MYLA MASTER DVD V4.1 CLI 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)). |
| Quantity | 626 systems in total |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and countries of: Foreign accounts: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, India, It… |
| Initiated | 2015-11-03 |
| Classified | 2015-12-16 |
| Terminated | 2017-12-04 |
| Recall number | Z-0429-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — bioMerieux, Inc. (Z-0429-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72643/
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