Medical diagnostic reagent recall: incorrect cell staining fluorescence
BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for serious harm (cancer misdiagnosis and delayed treatment). No illnesses, injuries, or deaths have been reported; the hazard is theoretical based on device performance failure. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a score of 3 (High).
Plain-English summary
BD Biosciences (Becton, Dickinson and Company) is recalling CD11b APC diagnostic reagent vials (REF 340936 and REF 333143, 464 total units) due to a manufacturing quality defect. The affected vials may produce low or dim fluorescence signals during laboratory cell staining procedures, which can result in false negative test results.
A false negative result could cause healthcare providers to misdiagnose or fail to detect hematological malignancies (blood cancers), potentially delaying critical treatment. Patients receiving incorrect test results may require additional blood samples to obtain accurate diagnostic findings.
The recalled vials have been distributed worldwide to clinical laboratories in multiple U.S. states and international locations. Laboratory personnel should immediately cease use of affected inventory and contact BD Biosciences for product replacement or return instructions. If patient samples have been tested with affected reagent, healthcare providers should consider retesting with replacement material to confirm diagnostic accuracy.
The recalled product
- Product
- CD11b APC: ASR, REF: 340936, and CE, REF: 333143
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 464
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- REF/UDI-DI/Expiration: 340936/00382903409365/20250228
- 333143/00382903331437/20250228
Distribution
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