Reported May 25, 2022 · Ongoing

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Bio-Rad Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bio-Rad Laboratories, Inc. · 6565 185th Ave Ne · Redmond, WA · 98052-5039

Is this the product you have?

  • BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Lot codes and dates
  • Model/Catalog Number12000670
  • UDI-DI (GTIN) Code03610520992715
  • Lot Number301388
Amount recalled
348 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.