VIDAS¿ CMV IgM 30 Tests
FDA Device Recall #Z-1408-2021 — Class II — March 16, 2021
Recall Summary
| Recall Number | Z-1408-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 16, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomerieux Inc |
| Location | Hazelwood, MO |
| Product Type | Devices |
| Quantity | 18705 kits |
Product Description
VIDAS¿ CMV IgM 30 Tests
Reason for Recall
bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
Distribution Pattern
Distributed nationwide to NY, CA, IL, WV, NJ, NY, TX, IN, PA, WI, VA, GA, CO, MI, FL, OH, MA, LA, NV, MO, CT and internationally to Argentina, Australia, Belgium, Brazil, Switzerland, Chile, Colombia, Czech Republic, Germany, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, Hungary, India, Italy, Japan, South Korea, Mexico, Netherlands, Philippines, Poland, Portugal, Russian Fed., Sweden, Singapore, Thailand, Turkey, South Africa, Algeria, Angola, Bahrain, Belarus, Benin, Bolivia, Bosnia-Herz., Bulgaria, Burkina Faso, Cameroon, Cape Verde, Chad, Costa Rica, Croatia, Dem. Rep. Congo, Dominican Rep., Dutch Antilles, Ecuador, El Salvador, Georgia, Guatemala, Indonesia, Iran, Iraq, Israel, Kenya, Lebanon, Lithuania, Macedonia, Mali, Malta, Mongolia, Morocco, Mozambique, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, Sril Lanka, Syria, Tunisia, Uruguay, Utd.Arab Emir., Vietnam, Djibouti, Equatorial Guin, Zambia, Cap Verde
Lot / Code Information
ref 30205; lot numbers 1008143230 (exp. date: 04 MAY 2021), 1008182270 (exp. date: 26 MAY 2021), 1008363970 (exp. date: 01 SEP 2021), 1008433580 (exp. date: 15 OCT 2021) US ref 30205-01; lot numbers 1008143260 (exp. date: 04 MAY 2021) and 1008363980 (exp. date: 01 SEP 2021)
Other Recalls from Biomerieux Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1236-2026 | Class II | VITEK 2 Gram-negative Susceptibility Cards Cont... | Jan 5, 2026 |
| Z-1464-2024 | Class I | VITEK 2 - AST Test kits (in vitro diagnostic te... | Mar 14, 2024 |
| Z-1201-2023 | Class II | MYLA comprises AST Filters in conjunction with ... | Feb 6, 2023 |
| Z-0798-2023 | Class II | VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700 | Nov 9, 2022 |
| Z-0786-2023 | Class II | API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 | Nov 9, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.