The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2428-2018·Announced 2018-07-18

bioMerieux Recalls mini VIDAS Systems Due to Performance Issues

bioMerieux is recalling 1,866 mini VIDAS systems because pump clogging and label displacement may cause erroneous 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes performance issues leading to erroneous results without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

bioMerieux, Inc. is recalling 1,866 units of the mini VIDAS System in combination with Quality Control VIDAS (QCV). The recall covers various models of the mini VIDAS analyzer distributed worldwide, including nationwide distribution across the United States and in numerous international countries.

The recall is due to an increase in events affecting performance, specifically 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 system due to a decrease of pipetted volume.

The mini VIDAS system is an immunodiagnostic system 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.

The recalled product

Product
BioMerieux mini 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.
Category
Medical Device — In Vitro Diagnostic (IVD)
Hazard
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 (18)

  • Description
  • Reference No. (UDI No.): MINI VIDAS ANALYSER EU
  • 99174 (03573026111021)
  • MINI VIDAS ANALYSER US
  • 99175 (03573026111045)
  • MINI VIDAS 100-120 VOLT VDE/CE
  • 99733 (03573026118662)
  • MINI VIDAS 200-240 VOLT VDE/CE
  • 99734 (03573026118655)
  • MINI VIDAS BLUE 110 / 220 V
  • 99737 (03573026140441)
  • MINI VIDAS ARKRAY ANALYZER
  • 99739 (03573026140465)
  • MINI VIDAS
  • 410416 (03573026351656)
  • W1421 (03573026029180)
  • MINIVIDAS INDUSTRY US
  • 421001 (03573026553319)

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

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.

See all 2 products in this recall →

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