Z-1408-2021 Class II Terminated
FDA device recall Z-1408-2021 was initiated by Biomerieux Inc on March 16, 2021 and is designated Class II. Reason for recall: bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01). The recall status is terminated (terminated August 6, 2024). Affected quantity: 18705 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- March 16, 2021
- Termination Date
- August 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18705 kits
Product Description
Reason for Recall
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