Reported Apr 21, 2021 · Terminated

VIDAS¿ CMV IgM 30 Tests

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 · 595 Anglum Rd · Hazelwood, MO · 63042-2320

Is this the product you have?

  • VIDAS¿ CMV IgM 30 Tests
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberProduct as published
30205
30205-01lot numbers 1008143230 (exp. date: 04 MAY 2021), 1008182270 (exp. date: 26 MAY 2021), 1008363970 (exp. date: 01 SEP 2021), 1008433580 (exp. date: 15 OCT 2021) US
lot numbers 1008143260 (exp. date: 04 MAY 2021) and 1008363980 (exp. date: 01 SEP 2021)
Amount recalled
18705 kits

Where it was sold

Why it was recalled

bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).

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 Aug 6, 2024 · Data as of Sep 19, 6:59 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.