Home / Recalls / Bio-Rad Laboratories, Inc. / Z-1572-2023

Z-1572-2023 Class II Ongoing

Recalled by Bio-Rad Laboratories, Inc. — Redmond, WA

Recall Details

Product Type
Devices
Report Date
May 17, 2023
Initiation Date
February 28, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
932 Reagent Packs

Product Description

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

Reason for Recall

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

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.

Code Information

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

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