Recall Z-2428-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
bioMerieux, Inc.
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 labora
| Date | May 9, 2018 (initiated Jan 4, 2018) |
| Status | Terminated |
| Reason | 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 | 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 st |
| Quantity | 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, Anguil |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923579 | MINIVIDAS INSTRUMENT Biomerieux Vitek, Inc., Feb 12, 1993 |