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Recall Observatory FDA recall evidence

Device 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.

Z-1214-2022

March 25, 2022

Class II

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
Event
Event 90028
Status
Ongoing
Classification
Class II
Quantity
249 units
Official record key
device-enforcement:Z-1214-2022

Official wording

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

Code information: Lot # 1064663; UDI: 00382903410989

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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