Recall Z-1215-2022 ยท MVU Reagents, Specific, Analyte
Becton, Dickinson and Company, BD Biosciences
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
| Date | Mar 25, 2022 |
| Status | Open, Classified |
| Reason | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. |
| Root cause | Process control |
| Action | On April 20, 2022, BD Biosciences issued a "Urgent Product Recall" notification via FeDEx to affected consignees. The firm ask consignees to take the following actions: 1. Immediately review your inventory for the specific Catalog and lot numbers listed above. Destroy all product subject to the recall following your institution s process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. If the product was used in LDTs to generate patient results, please also review potential impact t |
| Quantity | 199 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, DC, DE, FL, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the country of Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.