FDA-Device2022-09-21Class II
QIAcube Connect MDx, Model No. 9003070
Qiagen Sciences LLC
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.
Sold states
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.
Affected count
93 US; 57 OUS
Manufactured in
19300 Germantown Rd, Germantown, MD, United States
Products
QIAcube Connect MDx, Model No. 9003070
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1746-2022Don't want to check this manually?
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