CD11b APC: ASR, REF: 340936, and CE, REF: 333143 recallZ-0641-2024 · Becton, Dickinson and Company, BD Biosciences · initiated Oct 25, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton, Dickinson and Company, BD Biosciences or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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, [email protected] 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, [email protected]
Recall details
- Recall number
- Z-0641-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 25, 2023
- Posted by the FDA
- Jan 5, 2024
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Quantity
- 464 Vials
- Product code
- MVU
- 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.
Product description
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Code information (models, lots, serial numbers)
REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/A 340936Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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