# FDA recall Z-0641-2024

> **Becton, Dickinson and Company, BD Biosciences** · Class II · device recall initiated 2023-10-25.

## Product

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

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0641-2024
- **Recalling firm:** Becton, Dickinson and Company, BD Biosciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-25
- **Report date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0641-2024

## Citation

> AI Analytics. FDA recall Z-0641-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0641-2024. Source: US FDA. Licensed CC0.

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