BD Biosciences Recalls Mislabeled Anti EpCAM PE Reagent Lots
BD Biosciences is recalling two lots of Anti EpCAM PE reagent because the vials contain CD9 PE antibody instead of the labeled EpCAM antibody.
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, but the hazard is a labeling error in a research reagent without reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.
Plain-English summary
BD Biosciences, Systems & Reagents is recalling two lots of Anti EpCAM PE - Analyte Specific Reagent. The recall involves 12 units from lot 3295974 and 10 units from lot 3259822, both with an expiry date of 2015-09-30. The products were distributed worldwide, including in the United States (CA, TX, FL, MO, NY, MI, AZ) and Seoul, Korea.
The recall is due to a labeling error where the actual antibody present in the vials is CD9 PE, rather than the labeled Anti EpCAM antibody. This mislabeling could lead to incorrect experimental results if the reagent is used for its intended purpose.
Users of these specific lots should stop using the product and contact BD Biosciences for further instructions or a replacement.
The recalled product
- Product
- Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.
- Manufacturer
- BD Biosciences, Systems & Reagents
- Hazard
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)
- Catalog number 347211
- Lot number 3295974 - expiry date 2015-09-30
- Lot number 3259822 - expiry date 2015-09-30.
Distribution
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