FDA recall Z-1096-2022

Bio-Rad Laboratories, Inc. · Class II · device

Product

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Reason for recall

Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.

Key facts

Status: Ongoing
Initiation date: 2022-04-14
Report date: 2022-05-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1096-2022