Becton, Dickinson and Company, BD Biosciences Recall 90028
Description: 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.
Becton, Dickinson and Company, BD Biosciences Recall 90028 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1215-2022 |
| Event ID | 90028 |
| Event Description | 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. |
| Product Type | Devices |
| 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. |
| Quantity | 199 units |
| Recall Reason | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. |
| Device Classification | 20220608 |
| Device Code Info | Lot # 1228977; UDI: 00382903465873 |
| Center Classification Date | 20220601 |
| Recall Initiation Date | 20220325 |
| Recalling Firm | Becton, Dickinson and Company, BD Biosciences |
| Initial Notification | Letter |
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