Measles Antibody Test Kits Recalled Due to Temperature Excursion
Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.
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: This is a FDA Class II recall of a diagnostic device where temperature excursion has compromised product performance. Although no illnesses or injuries have been reported, the recall represents a risk of harm through inaccurate test results. Per the rubric, risk-of-harm products without reported injury receive a score of 3 (High).
Plain-English summary
Biomerieux Inc is recalling VIDAS Clinical VIDAS Measles IgG 60 Tests (Catalog 30219) distributed nationwide in the United States due to temperature and time excursions that exceeded acceptable limits during storage or transportation.
When diagnostic test kits experience such excursions, chemical reagents and test components may degrade, potentially affecting test accuracy and reliability. The manufacturer states that product performance cannot be guaranteed for affected units.
The recall involves 5 units with Batch Number 1009421810. Affected healthcare facilities, laboratories, or individuals should contact Biomerieux Inc to determine whether they received recalled product and to arrange for replacement or return.
The recalled product
- Product
- VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
- Manufacturer
- Biomerieux Inc
- Hazard
- storage-excursion
- performance-degradation
- inaccurate-results
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)
- UDI/DI 03573026064532
- Batch Numbers: 1009421810
Distribution
Distributed nationwide across the United States.
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