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Lower risk Medical device recall · FDA · Published January 4, 2018

BioMerieux VIDAS System QCV Recall: Pump Clogging Risks Erroneous Test Results

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2429-2018Medical deviceBioMerieux ›
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Contact the company

Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/72167-biomerieux-vidas-system-qcv-recall-pump-clogging-risks-erroneous-test.

Source Summary by GovInfoNow · govinfonow.com/recall/72167-biomerieux-vidas-system-qcv-recall-pump-clogging-risks-erroneous-test · Updated August 31, 2026 · FDA enforcement record: FDA #Z-2429-2018

Cite this page

“BioMerieux VIDAS System QCV Recall: Pump Clogging Risks Erroneous Test Results.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72167-biomerieux-vidas-system-qcv-recall-pump-clogging-risks-erroneous-test. Based on FDA recall #Z-2429-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2429-2018%22&limit=1).

The FDA announced on Jan. 4, 2018, that BioMerieux, Inc. voluntarily recalled its VIDAS System combined with Quality Control VIDAS (QCV) products due to a Class II hazard. The recall affects 1,866 units distributed worldwide and in all U.S. states.

How to tell if you have it

  • 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)
  • VIDAS ANALYSER US, W2205 (03573026029678)
  • VIDAS ANALYSER, 410417 (03573026351663)
  • Quality Control VIDAS (QCV), 30706 (03573026121631)
  • VIDAS ANALYSER EU, W3205 (03573026030292)
  • VIDAS INDUSTRY US, 421002 (03573026553319)

The hazard

According to the FDA, the recall addresses an increase in events affecting performance regarding pump clogging and displacement of the color-coded SPR label. These issues could contribute to erroneous results for any assay performed on the VIDAS and mini VIDAS systems due to a decrease of pipetted volume.

Context

GovInfoNow's records show Biomerieux Inc has had 36 other recalls on record since July 12, 2017. Recent recalls include the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), the Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and the Biomerieux VITEK 2 Gram-negative Susceptibility Cards recall (Jan. 5, 2026). Other recent recalls of similar products include the Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026), the Vivoo pH Test Recall (Nov. 22, 2025), and the Vivoo Vaginal pH Test Recall (Nov. 22, 2025).

How to tell if you have this one

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.

  • Brand
    BioMerieux
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY. International distribution to Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Cape Verde, Chad, Chile, China / Hong Kong, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guam, Guatemala, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Malta, Mauretania, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Netherlands, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Tanzania, Thailand, Togo, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Zimbabwe.
Recall numberProduct, codes & lots
Z-2428-2018BioMerieux 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 systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. The mini VIDAS¿ system is intended to execute an immunoassay protocol and to release results according to the package insert of the VIDAS¿ assay kits.; 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); MINI VIDAS, W1421 (03573026029180); MINIVIDAS INDUSTRY US, 421001 (03573026553319)
Z-2429-2018BioMerieux 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 systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. The mini VIDAS¿ system is intended to execute an immunoassay protocol and to release results according to the package insert of the VIDAS¿ assay kits.; 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); VIDAS ANALYSER US, W2205 (03573026029678); VIDAS ANALYSER, 410417 (03573026351663); Quality Control VIDAS¿ (QCV), 30706 (03573026121631); VIDAS ANALYSER EU, W3205 (03573026030292); VIDAS INDUSTRY US, 421002 (03573026553319)
Based on the official FDA remedy

What to do — step by step

  1. Check Product Model

    Identify the model number on the product packaging to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 46 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 4.3 years after the firm started it.

1. Firm started the recall: Jan 4, 201812. FDA classified it Class II: Jul 12, 201823. Published in FDA’s Enforcement Report: Jul 18, 201834. FDA terminated the recall: Apr 14, 2022420182022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-2429-2018 (January 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2429-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA