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Qiagen Sciences LLC recalls QIAcube Connect MDx, Model No. 9003070
Recalled September 21, 2022 · FDA recall Z-1746-2022 · Qiagen Sciences
Hazard
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results. · FDA Class II
Units
93 US; 57 OUS
Sold at
Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.
Description
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
Product
QIAcube Connect MDx, Model No. 9003070
Manufacturer(s)
Qiagen Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →