Device 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.
Z-1215-2022
Product summary
- Event
- Event 90028
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 199 units
- Official record key
device-enforcement:Z-1215-2022
Official wording
Reason: Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Code information: Lot # 1228977; UDI: 00382903465873
Distribution pattern: 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.
Derived failure modes
-
Unknown
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.