MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application ( Middleware...
FDA Device Recall #Z-0431-2016 — Class II — November 3, 2015
Recall Summary
| Recall Number | Z-0431-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 3, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | bioMerieux, Inc. |
| Location | Durham, NC |
| Product Type | Devices |
| Quantity | 626 systems in total |
Product Description
MYLA CLI V3.X TO V4.1 ML350 SERVER 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.
Distribution Pattern
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, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Angola, Puerto Rico, Republic of Belarus, Republic of Belarus, Benin, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Guam, Guatemala, Guatemala, Guinea, Honduras, Indonesia, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malaysia, Mali, Portugal, Myanmar, Managua, Niger, Nigeria, Palestine, Philippines, Philippines, Qatar, Kingdom of Saudi Arabia, Senegal, Serbia, Slovakia, Togo, Tunisia, Ukraine, UAE, Vietnam, Vietnam, Ivory Coast and Zimbabwe.
Lot / Code Information
REF # 419072, Serial number/Software version V4.1 CLI
Other Recalls from bioMerieux, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2671-2025 | Class II | VITEK¿ 2 Gram-negative AST Test Kits (Cards) co... | Jun 26, 2025 |
| Z-1564-2022 | Class II | NUCLISENS easyMAG Magnetic Silica, REF 280133, ... | Jul 20, 2022 |
| Z-1640-2022 | Class II | VITEK 2 / MYLA VITEK 2 Software versions 8.0... | Jul 13, 2022 |
| Z-1059-2022 | Class II | VITEK 2 Systems and VITEK 2 with MYLA. | Mar 29, 2022 |
| Z-0742-2022 | Class II | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. | Feb 9, 2022 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.