Class II
Medical Device Recall: Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Qiagen Sciences LLC · March 12, 2025
Reason for Recall
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Distribution
US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.
States Affected
AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, TX
Quantity Affected
445 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1504-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.