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 / number Product 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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