BioMerieux recalls Quality Control VIDAS (QCV) systems due to pump clogging and label displacement causing inaccurate test results. Affected lab equipment may need replacement to ensure reliable diagnostic testing.
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.
BioMerieux is recalling its Quality Control VIDAS (QCV) systems because pump clogging and displacement of the color-coded SPR label can lead to inaccurate test results. This affects laboratory equipment used for diagnostic testing in veterinary and industrial settings.
Pump clogging and displacement of the color-coded SPR label can cause the system to deliver less pipetted volume, leading to inaccurate test results. This may result in erroneous outcomes for any assay performed on the VIDAS or mini VIDAS systems.
Trained laboratory professionals using BioMerieux VIDAS systems for in vitro diagnostic testing in veterinary and industrial applications. The risk is low as the issue affects test accuracy rather than causing immediate safety hazards.
The Quality Control VIDAS (QCV) is part of the BioMerieux VIDAS System. Look for model numbers like 93296 (03573026133573), 93297 (03573026133580), or 30706 (03573026121631) on the product packaging.
Identify the model number on the product packaging to confirm if it is affected.
The recall is due to pump clogging and displacement of the color-coded SPR label, which can cause inaccurate test results.
Inaccurate test results may occur if the pump clogs or the SPR label moves, potentially leading to erroneous outcomes for any assay performed on the VIDAS or mini VIDAS systems.
Check the model number on the product packaging; affected models include 93296 (03573026133573), 93297 (03573026133580), and 30706 (03573026121631).
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2429-2018 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-2429-2018 from BioMerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
