FDAFDA · Food and drugs·Recall number Z-1215-2022
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.
Published June 8, 2022 · Recall initiated: March 25, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Distributor
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, DC, DE, FL, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the country of Taiwan.
- Lot
- Lot # 1228977; UDI: 00382903465873
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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