Biomerieux Inc Recall 87555
Description: VIDAS¿ CMV IgM 30 Tests
Biomerieux Inc Recall 87555 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1408-2021 |
| Event ID | 87555 |
| Event Description | VIDAS¿ CMV IgM 30 Tests |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 18705 kits |
| Recall Reason | bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01). |
| Device Classification | 20210421 |
| Device Code Info | 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) |
| Center Classification Date | 20210410 |
| Recall Initiation Date | 20210316 |
| Recalling Firm | Biomerieux Inc |
| Initial Notification | |
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