Recall Z-1971-2020 ยท MVU Reagents, Specific, Analyte
Becton, Dickinson and Company, BD Biosciences
Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and b
| Date | May 13, 2020 (initiated Mar 31, 2020) |
| Status | Terminated |
| Reason | False positive reaction on the reagent. |
| Root cause | Nonconforming Material/Component |
| Action | URGENT MEDICAL DEVICE RECALL letter was sent to the customers on 03/31/2020 via FedEx, emailed or faxed. The acknowledgement form included with the letter that is mailed, faxed, emailed, back to BD will be reconciled with the customer list. |
| Quantity | 1473 vials. |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI and Puerto Rico. The countries of Argentina, Australia, Belgium, Brazil, Canada, China, Hong Kong, India, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.