Recall Z-1746-2022 ยท JJH Clinical Sample Concentrator
Qiagen Sciences LLC
QIAcube Connect MDx, Model No. 9003070
| Date | Nov 21, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Other |
| Action | Customers were notified of the initial issue by email beginning Nov 3 2021, and requested to return acknowledgment of the notice. On January 26, 2022, a new version of the protocol software was released and customers were advised of the new protocol availability and acknowledge download via a follow up notice. |
| Quantity | 93 US; 57 OUS |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.