Recall Z-1408-2021 ยท LKQ Antibody Igm,If, Cytomegalovirus Virus
Biomerieux Inc
VIDAS CMV IgM 30 Tests
| Date | Mar 16, 2021 |
| Status | Terminated |
| Reason | bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01). |
| Root cause | Under Investigation by firm |
| Action | A Recall notification letter titled, "IMPORTANT: URGENT FIELD SAFETY NOTICE" was sent to the to the impacted subsidiaries and distributors on 03/16/2021 via email. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The recalling firm requested that the consignees conduct the following actions: 1 - Please distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferre |
| Quantity | 18705 kits |
| 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, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933549 | VIDAS CMV IGM ASSAY Biomerieux Vitek, Inc., Aug 2, 1994 |