FDA Medical Device Recalls (openFDA)
Becton, Dickinson and Company, BD Biosciences: CD11b APC: ASR, REF: 340936, and CE, REF: 333143
- Recall number
- Z-0641-2024
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Product
- CD11b APC: ASR, REF: 340936, and CE, REF: 333143
- Status
- Open, Classified
- Initiated
- 2023-10-25
- Posted
- 2024-01-05
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On 10/25/2023, correction notices were mailed and emailed to customers who were asked to do the following: 1) Discard all products subject to the recall following your institution s process for destruction. 2) Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 3) If lot 3114730 was used, review results and take appropriate action as deemed necessary. 4) Complete and return the response form via email, BDRC26@bd.com or via Link, https://bdx.my.site.com/CC360/s/impactedproducts?rn=BDB-23-4854 Customers who require further assistance can contact the firm's North American Regional Complaint Center via phone, 1-844-823-5433, say "recall" when prompted Mon-Fri 8:00am and 5:00pm CT, or via email, productcomplaints@bd.com
- Quantity
- 464 Vials
- 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.
- Lot, serial or model codes
- REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 2916837
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28