VIDAS CMV IgM diagnostic test kits recalled for invalid calibrations
bioMerieux is recalling 480 VIDAS CMV IgM test kits with invalid calibrations distributed across 18 U.S. states. The calibration errors may affect diagnostic test accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic device with invalid calibrations affecting test accuracy. No reported illnesses or adverse events, but the calibration defect presents a risk of diagnostic error and potential patient harm.
Plain-English summary
bioMerieux, Inc. is recalling 480 VIDAS CMV IgM diagnostic test kits (Reference 30205-01, 30 tests per kit) distributed to government facilities across 18 U.S. states. The recalled lot is 1008873260 with an expiration date of June 1, 2022.
The kits were recalled due to invalid calibrations that read out of the acceptable range, specifically higher than the normal range. This calibration error affects the accuracy of test results produced by the kits.
The affected states are California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Missouri, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Wisconsin, and West Virginia.
The recalled product
- Product
- VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 480
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot numbers 1008873260
- exp. 01JUN2022.
Distribution
Related recalls
Same manufacturer · bioMerieux, Inc.
See all →- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
- HighMedical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
FDA (Devices) · 2023-03-08
Same hazard · calibration error
See all →- ModeratePhotera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 3-D phototherapy device UV sensor calibration error recall
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 Phototherapy Device UV Sensor Calibration Error
FDA (Devices) · 2026-07-22
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11