# FDA recall Z-2429-2018

> **bioMerieux, Inc.** · Class II · device recall initiated 2018-01-04.

## 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.

## 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.

## 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, Mongol

## Key facts

- **Recall number:** Z-2429-2018
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-04
- **Report date:** 2018-07-18
- **Termination date:** 2022-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2429-2018

## Citation

> AI Analytics. FDA recall Z-2429-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2429-2018. Source: US FDA. Licensed CC0.

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