Z-1572-2023 Class II Ongoing
FDA device recall Z-1572-2023 was initiated by Bio-Rad Laboratories, Inc. on February 28, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 932 Reagent Packs.
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