CLASS II ONGOING Device recall · Reported 7 Dec 2022 · FDA Enforcement Report

CMV IgM EIA, in vitro diagnostic recalled by Bio-Rad Laboratories

Bio-Rad Laboratories is recalling CMV IgM EIA, in vitro diagnostic, distributed in 14 states. The recall was initiated on 19 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022

Quantity recalled180 kits

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-0342-2023
FDA event ID: 91106
Recalling firm: Bio-Rad Laboratories, Redmond, WA
Classification: Class II
Status: Ongoing
Recall initiated: 19 Oct 2022
FDA classified: 30 Nov 2022
Reported: 7 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

19 Oct 2022	Recall initiated by company
30 Nov 2022	Classified by FDA	+42 days
7 Dec 2022	Published in enforcement report	+7 days

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

Reason for recall

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

CMV IgM EIA, in vitro diagnostic.

Where it was distributed

U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None

California Colorado Florida Georgia Hawaii Iowa Massachusetts Minnesota North Carolina New Hampshire New Jersey Pennsylvania Tennessee Texas

Questions about this recall

Is CMV IgM EIA, in vitro diagnostic recalled?

Yes. Bio-Rad Laboratories recalled CMV IgM EIA, in vitro diagnostic on 19 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0342-2023.

Why was it recalled?

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

Which lots are affected?

Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022

Where was it sold?

U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None

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 21 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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