BD Mouse IgG2a Antibody Reagent Recalled for Manufacturing Contamination
This antibody reagent was recalled due to manufacturing contamination that may produce false positive staining results in laboratory tests. The affected lot was distributed worldwide.
What this means for you
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: This is a Class II medical device recall involving a manufacturing quality control defect that compromises test accuracy through antibody contamination. No injuries or illnesses have been reported, and the hazard is theoretical (false positive staining), placing it at the Moderate severity level per the rubric.
Plain-English summary
The BD Mouse IgG2a Isotype Control APC X39 ASR is a laboratory antibody reagent used in research and testing. Manufactured by Becton, Dickinson and Company (BD Biosciences), it is supplied as a kit containing 23 reagents.
Complaints have been received regarding performance issues characterized by high background and staining. The root cause is a manufacturing process error that led to contamination of the affected lot with another antibody, potentially causing false positive staining results.
The affected lot (Lot Number 0253432, Catalog Number 340757, UDI 00382903407576) was distributed worldwide. In the United States, distribution occurred in Connecticut, Florida, Kentucky, New York, and Pennsylvania. The product was also distributed to Taiwan.
The recalled product
- Product
- BD" Mouse IgG2a Isotype Control APC X39 ASR
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Category
- Medical Device
- Hazard
- contamination
- manufacturing-defect
- false-positive-staining
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 (1)
- Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432
Distribution
Distributed nationwide across the United States.
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