CLASS II ONGOING Device recall · Reported 25 May 2022 · FDA Enforcement Report

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack recalled

Bio-Rad Laboratories is recalling BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack, distributed nationwide in the US. The recall was initiated on 14 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388

Quantity recalled348 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1096-2022
FDA event ID: 90026
Recalling firm: Bio-Rad Laboratories, Redmond, WA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Apr 2022
FDA classified: 16 May 2022
Reported: 25 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

14 Apr 2022	Recall initiated by company
16 May 2022	Classified by FDA	+32 days
25 May 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Where it was distributed

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.

Nationwide Arkansas Arizona California Florida Hawaii Iowa Illinois Michigan Minnesota Nebraska New York Tennessee Texas Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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