Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2024 - (Recall #: Z-0641-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

CD11b APC: ASR, REF: 340936, and CE, REF: 333143

Product Classification:

Class II

Date Initiated: October 25, 2023

Date Posted: January 17, 2024

Recall Number: Z-0641-2024

Event ID: 93569

Reason for Recall:

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

Status: Ongoing

Product Quantity: 464 Vials

Code Information:

REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228

Distribution Pattern:

Worldwide - US Nationwide distribution including in the states of IL, MN, FL, MI, MD, NC, NY, CA, GA, AR, KS, PA, NH, TX, OK, MA, MO, DC, AZ, IN, NJ, TN, WA, VA, CT and the countries of CA, BE, SG, HK, TW, BR, MY, IN, BO, PE, JP, MX, CL, KR, UY, AU.

Voluntary or Mandated:

Voluntary: Firm initiated