The Recall Desk

FDA (Devices) recall action 79993

bioMerieux, Inc. recalled 2 products on 2018-07-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-07-18
Critical
0
Units
3,732

Why these products were recalled

Increase of events affecting performance regarding pump clogging and 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 agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-07-18

    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.

    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 system
    Category
    Distribution
    47 states
  • ModerateFDA (Devices)··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.

    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 s
    Category
    Distribution
    47 states