BD Biosciences Recalls CD45 Reagent Due to False Positive Reactions
Becton, Dickinson and Company is recalling 1,473 vials of Analyte specific reagent (CD45) because of false positive reactions. The product is used for in vitro diagnostic testing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a false positive reaction, which is a diagnostic error rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for moderate severity.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences, is recalling 1,473 vials of Analyte specific reagent, specifically the CD45 APC-H7 reagent. The recall is being conducted because the reagent may produce false positive reactions. The product is intended for in vitro diagnostic use to identify cells expressing the CD45 antigen using a BD FAC brand flow cytometer.
The affected product was distributed worldwide, including nationwide in the United States and in various countries such as Argentina, Australia, Belgium, Brazil, Canada, China, and others. Specific lot numbers involved in the recall are 9057729, 9056804, and 9065949.
Users of this product should stop using the affected vials and contact Becton, Dickinson and Company for further instructions or a return. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC…
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Hazard
- Affected units
- 1,473
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 (3)
- Analyte specific reagent - BD CD45 APC-H7. REF/ Lot Number: 641408/9057729
- 541417/9056804
- 641399/9065949
Distribution
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