Recall Z-1215-2022— Becton, Dickinson and Company, BD Biosciences
Class II · Ongoing
Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2022-03-25. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.. Reason: Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles..
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-25
- Firm location
- San Jose, CA, United States
Product description
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
Reason for recall
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Data sourced from openFDA. This site is unofficial and independent of the FDA.