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FDA (Device enforcement)Recalled 2022-03-25class ii

Becton, Dickinson and Company, BD Biosciences: 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 h

Is my product affected?

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.

  • UPC 00382903410989

Check against the official notice below — it lists the full affected range.

What happened

Becton, Dickinson and Company is recalling BD Anti-Kappa APC and Anti-Kappa PE analyte reagents because they may exhibit uncharacteristic flow profiles. The affected products include 249 units from Lot #1064663 with UDI 00382903410989. These reagents were distributed worldwide, including throughout multiple U.S. states (Alabama, California, Colorado, District of Columbia, Delaware, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia) and Taiwan.

The source does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. 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. Quantity: 249 units Lot/code info: Lot # 1064663; UDI: 00382903410989

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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