BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Check against the official notice below — it lists the full affected range.
Bio-Rad Laboratories, Inc. is recalling 348 units of the BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack (Lot Number 301388) due to performance concerns with the CMV IgM analyte. The reagent pack has demonstrated variable elevated background levels depending on how the reagent pack was handled. The affected product was distributed worldwide and in the U.S. states of Arkansas, Arizona, California, Florida, Hawaii, Iowa, Illinois, Michigan, Minnesota, Nebraska, New York, Tennessee, Texas, and Washington, as well as in the Czech Republic, France, Germany, and Italy.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the 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. Quantity: 348 units Lot/code info: Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.