Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1746-2022 — QIAcube Connect MDx, Model No. 9003070

U.S. FDA — Device Enforcement · United States · 2021-11-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1746-2022
Date of alert
2021-11-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Qiagen Sciences LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04053228039129
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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