Recall Z-1746-2022— Qiagen Sciences LLC
Class II · Ongoing
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2021-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: QIAcube Connect MDx, Model No. 9003070. Reason: 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..
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-21
- Firm location
- Germantown, MD, United States
Product description
QIAcube Connect MDx, Model No. 9003070
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.