Reported Apr 9, 2025 · Ongoing
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version:…
Qiagen Sciences LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415
Is this the product you have?
- Brand NameQIAstat-Dx
- Product NameQIAstat-Dx Respiratory
- Panel Plus Reference Number (REF)691224
- Software Versionn/a
- Componentn/a
- Lot codes and dates
REF 691224Lot 178038604
- UDI-DI04053228047438
- affected Serial numbers (SNs)
200 of 200 codes
332168961332168962332168963332168964332168972332168978332168979332168980332168990332168996332169005332169012332169013332169015332169016332169021332169022332169023332169024332169031332169032332169033332169034332169039332169040332169041332169042332169047332169048332169049332169050332169055332169056332169057332169060332169065332169066332169073332169074332169083332169084332169085332169086332169091332169092332169093332169094332169099332169101332169102332169107332169108332169109332169110332169115332169116332169117332169118332169123332169125
- Amount recalled
- 445 units
Where it was sold
Why it was recalled
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
This product could cause temporary or reversible health problems — stop using it.
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