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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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