Bio-Rad Laboratories, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1572-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 28, 2023

Date Posted: May 17, 2023

Recall Number: Z-1572-2023

Event ID: 91889

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.

Status: Ongoing

Product Quantity: 932 Reagent Packs

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.

Voluntary or Mandated:

Voluntary: Firm initiated