Z-1214-2022 Class II Ongoing
FDA device recall Z-1214-2022 was initiated by Becton, Dickinson and Company, BD Biosciences on March 25, 2022 and is designated Class II. Reason for recall: Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. The recall status is ongoing. Affected quantity: 249 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2022
- Initiation Date
- March 25, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 249 units
Product Description
BD Anti-Kappa APC (Cat. No. 341098) 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 for Recall
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
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.
Code Information
Lot # 1064663; UDI: 00382903410989