QIAcube Connect MDx, Model No. 9003070
Reported: September 21, 2022 Initiated: November 21, 2021 #Z-1746-2022
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.
Details
- Recalling Firm
- Qiagen Sciences LLC
- Units Affected
- 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.
- Location
- Germantown, MD
Frequently Asked Questions
What product was recalled? ▼
QIAcube Connect MDx, Model No. 9003070. Recalled by Qiagen Sciences LLC. Units affected: 93 US; 57 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Moderate. Recall number: Z-1746-2022.
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