BioMerieux VIDAS System in combination with Quality Control… recallZ-2429-2018 · bioMerieux, Inc. · initiated Jan 4, 2018

Why it was 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.

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number

Z-2429-2018

Status

Terminated

Initiated by the company

Jan 4, 2018

Posted by the FDA

May 9, 2018

Recalling firm

bioMerieux, Inc.

Quantity

1,866 units

Product code

JJE

FDA submissions

K923579

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 description

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• VIDAS® Quality Control 30706

  Biomerieux SA · Multi-analyte controls unassayed
  2 recalls0 reports
• VIDAS® 99735

  Biomerieux SA · Igg, Antigen, Antiserum, Control
  1 recall36 reports

Other devices under the same FDA submission

1 device cleared under K923579 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• mini VIDAS® 99737

  Biomerieux SA · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  1 recall73 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 79993).

• Z-2428-2018 · 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 d…