Terminated

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 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.

FDA Recall Z-2428-2018 · Posted 2018-05-09

Recalling FirmbioMerieux, Inc.

Recall StatusTerminated

Product CodeJJE

Date Initiated2018-01-04

Date Terminated2022-04-14

Product Quantity1,866 units

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.

Firm 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

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923579MINIVIDAS INSTRUMENTBiomerieux Vitek, Inc. · 1993-02-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.