BD CD64 APC-R700 Reagent Recalled Due to CD4 Antibody Contamination
Becton, Dickinson and Company is recalling three lots of CD64 APC-R700 reagent because they are contaminated with CD4 antibody, which may cause unexpected staining patterns.
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 involves contamination leading to unexpected staining patterns, which is a quality issue affecting test results but does not indicate direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences is recalling three lots of BD CD64 APC-R700 Analyte Specific Reagent, Model 657701. The affected lots are 4344945, 5037611, and 5063945. The total quantity involved is 23 vials.
The recall is being issued because the CD64 (MD22) reagent is contaminated with CD4 antibody. This contamination leads to the possibility of unexpected staining patterns when the product is used as an analyte specific reagent in hematology.
The product was distributed in the states of Florida, Washington, Pennsylvania, Illinois, Georgia, Rhode Island, Texas, North Dakota, and Iowa. Users of this product should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 23
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 (5)
- Model 657701
- Lot No. 4344945
- 5037611
- both with expiry date of 31 DEC 2015
- and 5063945 with expiry dte of 29 FEB 2016.
Distribution
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