Every recall we track for Qiagen Sciences LLC — 20 in all — plus the complaints and injury reports the public filed about them.
Qiagen recalls QIAstat-Dx Respiratory Panel Plus cartridges with serial numbers listed. Faulty cartridges may cause false test results if used for sample testing. Affected units include specific serial numbers.
Qiagen recalls QIAcube Connect MDx instruments with heater shaker modules that may not heat below 40°C, causing delayed or erroneous DNA results. Affected units have serial numbers 30000-30506.
Qiagen recalls EZ2 Connect MDx-IVD molecular diagnostic devices due to heater cable issues that can cause sample loss. Affected models include 9003230 and many other serial numbers listed. No remedy specified in recall notice.
Qiagen recalls specific SARS-CoV-2 test cartridges that may produce false negative results due to faulty manufacturing. Affected units include certain lot and serial numbers from the QIAstat-Dx Respiratory SARS-CoV-2 Panel test.
Qiagen recalls Therascreen FGFR RGQ RT-PCR kits due to false positive results that may lead to incorrect cancer treatment. Affected kits have specific lot numbers and expiration dates.
Qiagen recalls Therascreen FGFR RGQ RT-PCR Kit (CE IVD) due to increased false positives, which could lead to incorrect cancer treatment decisions. Affected kits have specific lot numbers and expiration dates.
Qiagen recalls FGFR RGQ RT-PCR Kit (RUO) with risk of false positive results causing incorrect cancer treatment reports. Affected units have specific lot numbers and expiration dates.
Qiagen recalls KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD) due to potential false positive/negative mutation results. Affected units may need retesting for accurate genetic testing.
Qiagen recalls KRAS RGQ PCR Kit (24) Model REF 870021 due to false positive/negative results for KRAS mutations, potentially invalidating test outcomes.
Qiagen recalls QIAcube Connect MDx (Model 9003070) due to incorrect volume guidance during sample loading, which may cause false negative or positive test results. Affected units have specific serial numbers listed in the recall notice.
Qiagen recalls 16 faulty SARS-CoV-2 test cartridges (LOT 210209) that may cause false negative or positive results. Affected units have specific serial numbers.
Qiagen recalls SARS-CoV-2 Antigen Test kits with potential for false positives in some patient samples. Learn about affected lots and how to handle the product.
Qiagen recalls PIK3:3CA RGQ PCR Kit (23) US IVD product due to potential false positive results for breast cancer mutation testing. Affected kits may misidentify patients for PIQRAY treatment.
Qiagen recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 due to increased false positives for Influenza A, risking incorrect treatment and delayed diagnosis. Affected units include specific lots.
Qiagen recalls Therascreen EGFR RGQ PCR Kit (24) due to rare false mutation positive results from fluorescence artefacts. All lots affected. No remedy specified.
Qiagen recalls AmniSure ROM Test kits with incorrect rinse time instructions. The correct rinse time is 1 minute, not 30 seconds. Affected kits include specific US and Canadian models.
Qiagen recalls software version 2.3.4 for Rotor Gene Q PCR analyzers that may report false negative results in certain tests, risking treatment suspension or non-initiation of medical treatment.
Qiagen recalls software version 5.0.3 for QIAsymphony SP instruments due to potential incorrect patient reporting if 2D bar codes aren't verified before downstream applications. Affected units include specific serial numbers listed in the recall.
Qiagen recalls Filter-Tips (1500 ul) used with QIAsymphony SP/AS instruments due to leaking tips in some lots. Affected lots: 0605020019 and 0605020020. Stop using if leaking.
Qiagen recalls EZ1 Advanced XL model 9001492 due to potential heater malfunction from a power PCB issue, which may require repeating nucleic acid extractions and delaying results.
