# FDA recall Z-1746-2022

> **Qiagen Sciences LLC** · Class II · device recall initiated 2021-11-21.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1746-2022
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-21
- **Report date:** 2022-09-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Germantown, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1746-2022

## Citation

> AI Analytics. FDA recall Z-1746-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1746-2022. Source: US FDA. Licensed CC0.

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