Z-2429-2018Class II

BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*)

Name: Z-2429-2018 BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*)
Creator: bioMerieux, Inc.
Published: 2018-01-04
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-01-04 / Terminated / root cause: design

FDA source

bioMerieux, Inc. began a recall of 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... on 2018-01-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2429-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-04
Posted: 2018-05-09
Terminated: 2022-04-14
Recalling firm: bioMerieux, Inc.
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 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Subsidiaries and distributors were initially notified of the recall on approximately 01/04/2018. U.S. customers were notified via letter on approximately 01/22/2018. On 03/28/2018 a follow-up notification was issued world-wide to customers to expand the scope. Instructions included to increase the frequency of the Quality Control VIDAS (QCV) testing to weekly rather than monthly to reduce the period of potential retrospective analyses needed, continue to conduct a visual inspection of the SPR after each run (including patient sample test and QCV test) to ensure that the dot on the SPR is still in place, continue to perform External QC testing in accordance with laboratory policy and in compliance with Governmental Regulations & Accreditation Requirements, which includes CLIA, ensure the notification letter is distributed to and reviewed by all appropriate personnel, store the notification letter with the bioMrieux VIDAS and /or miniVIDAS documentation, and complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of the notice. For further questions, please call (314) 731-8694
Quantity in commerce: 1,866 units
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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2429-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2428-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-12
Z-2429-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-12

Product code JJE

K923579Class IMinividas InstrumentBiomerieux Vitek, Inc. / cleared 1993-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)