BD" Mouse IgG2a Isotype Control APC X39 ASR recall: Contamination
BD" Mouse IgG2a Isotype Control APC X39 ASR
Why was BD" Mouse IgG2a Isotype Control APC X39 ASR recalled?
Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432
- Product
- BD" Mouse IgG2a Isotype Control APC X39 ASR
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Quantity
- 23 reagents
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.
- Recall date
- September 1, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)