FDA-Device2025-04-09Class II
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
Hazard
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Sold states
US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.
Affected count
445 units
Manufactured in
19300 Germantown Rd, Germantown, MD, United States
Products
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1504-2025Don't want to check this manually?
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