BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific… recallZ-1214-2022 · Becton, Dickinson and Company, BD Biosciences · initiated Mar 25, 2022

Why it was recalled

Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

FDA root cause category: Process control

What the company is doing

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

Recall details

Recall number

Z-1214-2022

Status

Open, Classified

Initiated by the company

Mar 25, 2022

Recalling firm

Becton, Dickinson and Company, BD Biosciences

Quantity

249 units

Product code

MVU

Distribution

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.

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• N/A 341098

  Becton, Dickinson And Company · Reagents, specific, analyte
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 90028).

• Z-1215-2022 · Open, Classified
  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-K…