bioMerieux Recalls VIDAS Analyzers and Quality Control Tests for Performance Issues
bioMerieux is recalling VIDAS analyzers and Quality Control VIDAS tests due to pump clogging and label displacement that may cause erroneous assay 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 is classified as FDA Class II. The hazard involves a risk of erroneous diagnostic results due to performance issues, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
bioMerieux, Inc. is recalling the BioMerieux VIDAS System in combination with Quality Control VIDAS (QCV) tests. The recall involves 1,866 units distributed worldwide, including nationwide distribution in the United States and to numerous international locations.
The recall is due to an increase in events affecting performance, specifically regarding pump clogging and the displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS and mini VIDAS systems due to a decrease in pipetted volume.
The VIDAS and mini VIDAS systems are immunodiagnostic systems intended to be used by trained and qualified laboratory professionals for in vitro diagnostic (IVD) purposes, veterinary, and industrial applications. The Quality Control VIDAS (QCV) is an automated test used to detect abnormal operation of the instrument's pipette mechanisms and optical systems. No specific instructions for consumers are provided in the source text, but the affected products are intended for professional laboratory use.
The recalled product
- Product
- BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical…
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 1,866
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 (20)
- Description
- Reference No. (UDI No.): VIDAS ANALYSER 110/220V
- 93296 (03573026133573)
- VIDAS ANALYSER 220V
- 93297 (03573026133580)
- VIDAS ANALYSEUR
- 99011 (03573026109257)
- VIDAS ANALYSER EU
- 99444 (03573026114060)
- VIDAS ANALYSER US
- 99445 (03573026114084)
- VIDAS ANALYSER
- 99735 (03573026140427)
- W2205 (03573026029678)
- 410417 (03573026351663)
- Quality Control VIDAS¿ (QCV)
- 30706 (03573026121631)
- W3205 (03573026030292)
- VIDAS INDUSTRY US
- 421002 (03573026553319)
Distribution
Part of a larger recall action
This product is one of 2 recalled by bioMerieux, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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