FDA Device recall Z-1215-2022
BD Anti-Kappa PE (Cat
- FDA Device
- Class II
- ongoing
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of BD Anti-Kappa PE (Cat by Becton Dickinson And Bd Biosciences, citing anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1215-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-25 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | US |
Product
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.
Reason
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Identifiers
| code_info | Lot # 1228977; UDI: 00382903465873 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2022%22
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