Recall Z-2333-2021— Becton, Dickinson and Company, BD Biosciences
Class II · Terminated
Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2021-07-22, terminated 2023-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: BD" Mouse IgG2a Isotype Control APC X39 ASR. Reason: 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..
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-22
- Terminated
- 2023-03-24
- Firm location
- San Jose, CA, United States
Product description
BD" Mouse IgG2a Isotype Control APC X39 ASR
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.