Biomerieux VIDAS 3 Immunoanalyzer Recalled for False Results Due to Software Error
Biomerieux Inc is recalling 738 VIDAS 3 immunoanalyzers because a software defect may allow expired calibrations to be used without warning, potentially causing false test results.
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: The recall involves a medical device where a software defect can lead to false test results. This poses a risk of harm to patients through incorrect diagnostic information, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biomerieux Inc is recalling 738 units of the VIDAS 3 Compact immunoanalyzer. The recall is due to a software defect that incorrectly updates the calibration status of assays. This error allows the software to compute analysis results for assays with expired calibrations, even though the calibration menu displays them as valid. Additionally, the system fails to display an alarm to warn users about the expiration date of the calibrations.
The recall was initiated following customer complaints regarding potentially false results obtained on the VIDAS 3. The anomaly is attributed to the incorrect update of the calibration status by the software. The affected units are those running software versions 1.2 and higher. The distribution pattern for these units is the United States.
Users of the VIDAS 3 immunoanalyzer should contact Biomerieux Inc for further instructions on how to address the software defect and ensure accurate calibration status.
The recalled product
- Product
- BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
- Manufacturer
- Biomerieux Inc
- Affected units
- 738
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 (1)
- software versions 1.2 and higher
Distribution
Distribution scope not specified by the agency.
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