BD Anti-Kappa APC (BD Biosciences) – flow profile issue (2022)
Analyte reagents may exhibit uncharacteristic flow profiles during testing.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD Anti-Kappa APC (Cat. No. 341098) 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.
Brand
Becton, Dickinson and Company, BD Biosciences
Lot Codes / Batch Numbers
Lot # 1064663, UDI: 00382903410989
Products Sold
Lot # 1064663; UDI: 00382903410989
Becton, Dickinson and Company, BD Biosciences is recalling BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, whic due to Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Recommended Action
Per FDA guidance
On April 20, 2022, BD Biosciences issued a "Urgent Product Recall" notification via FeDEx to affected consignees. The firm ask consignees to take the following actions: 1. Immediately review your inventory for the specific Catalog and lot numbers listed above. Destroy all product subject to the recall following your institution s process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. If the product was used in LDTs to generate patient results, please also review potential impact to patient results following your institution s policies. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any of the affected lots in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated. 5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via the: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) or Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026