FDA Medical Device Recalls (openFDA)
Becton, Dickinson and Company, BD Biosciences: 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.
- Recall number
- Z-1215-2022
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- 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.
- Status
- Open, Classified
- Initiated
- 2022-03-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
- Root cause
- Process control
- Action
- 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
- Quantity
- 199 units
- 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.
- Lot, serial or model codes
- Lot # 1228977; UDI: 00382903465873
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 2916837
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28