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Open, Classified

QIAcube Connect MDx, Model No. 9003070

FDA Recall Z-1746-2022 · Posted None

Recalling FirmQiagen Sciences LLC
Recall StatusOpen, Classified
Product CodeJJH
Date Initiated2021-11-21
Product Quantity93 US; 57 OUS

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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