Reported Oct 5, 2022 · Terminated

VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

bioMerieux, 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: bioMerieux, Inc. · 100 Rodolphe St · Durham, NC · 27712-9402

Is this the product you have?

  • VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Lot codes and dates
    • Lot numbers 1008873260
    • exp. 01JUN2022
Amount recalled
480 kits

Where it was sold

Why it was recalled

Invalid calibrations (out of range high) while using the product.

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

Notice updated Apr 1, 2026 · Data as of Sep 19, 7:36 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.