Z-1215-2022Class II

BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which...

Name: Z-1215-2022 BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2022-03-25
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2022-03-25 / Open, Classified / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of 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... on 2022-03-25. FDA classified it as Class II and gives the reason as "Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1215-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-25
Posted: 2022-06-01
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.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot # 1228977; UDI: 00382903465873

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1215-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1214-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-01
Z-1215-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-01

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)