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
Check against the official notice below — it lists the full affected range.
BioMerieux, Inc. is recalling 1,866 units of the BioMerieux mini VIDAS System used in combination with Quality Control VIDAS (QCV) products. The recall was initiated due to an increase in performance issues including pump clogging and displacement of the color-coded SPR label. These problems can reduce the volume of liquid dispensed during testing, potentially leading to inaccurate test results for any assay performed on the VIDAS or mini VIDAS systems.
The affected devices were distributed worldwide and throughout most U.S. states, as well as internationally to numerous countries. Multiple versions of the mini VIDAS analyzer are included in the recall, identified by various reference numbers and UDI codes. The recall record does not specify a remedy or recommended action for consumers who may have affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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, B Quantity: 1,866 units Lot/code info: Description, Reference No. (UDI No.): MINI VIDAS ANALYSER EU, 99174 (03573026111021); MINI VIDAS ANALYSER US, 99175 (03573026111045); MINI VIDAS 100-120 VOLT VDE/CE, 99733 (03573026118662); MINI VIDAS 200-240 VOLT VDE/CE, 99734 (03573026118655); MINI VIDAS BLUE 110 / 220 V, 99737 (03573026140441); MINI VIDAS ARKRAY ANALYZER, 99739 (03573026140465); MINI VIDAS, 410416 (03573026351656); MINI VIDAS, W1421 (03573026029180); MINIVIDAS INDUSTRY US, 421001 (03573026553319)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.