Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2022 - (Recall #: Z-1215-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: March 25, 2022

Date Posted: June 8, 2022

Recall Number: Z-1215-2022

Event ID: 90028

Reason for Recall:

Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

Status: Ongoing

Product Quantity: 199 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated