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Recall Observatory FDA recall evidence

Device product

BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

Z-1572-2023

February 28, 2023

Class II

Product summary

Firm
Bio-Rad Laboratories, Inc.
Event
Event 91889
Status
Ongoing
Classification
Class II
Quantity
932 Reagent Packs
Official record key
device-enforcement:Z-1572-2023

Official wording

Reason: APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

Code information: Lot Code: 301538; UDI-DI: (00)847865000666

Distribution pattern: US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.