Reported Jan 12, 2022 · Terminated
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
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?
- QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
- Lot codes and dates
- LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223
- Serial Numbers
412092551412092559412092552412092560412092553412092561412092554412092563412092555412092564412092556412092565412092557412092566412092558412092567
- Amount recalled
- 376 kits
Where it was sold
Why it was recalled
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
This product could cause temporary or reversible health problems — stop using it.
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