Bio-Rad Laboratories, Inc.: BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

Hazard

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

Details from the source

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: 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. Quantity: 932 Reagent Packs Lot/code info: Lot Code: 301538; UDI-DI: (00)847865000666

UPC codes

847865000666

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.