Qiagen Sciences recalls
8 official recalls and safety alerts involving Qiagen Sciences since 2022-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Qiagen Sciences or the relevant agency.
- 2025-04-09
USQiagen Sciences LLC recalls Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
FDA · DeviceQiagen Sciences LLCUS Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.Official notice →- 2024-07-24
- US
Qiagen Sciences LLC recalls QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic…
Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA…
FDA · DeviceQiagen Sciences LLCNationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB,…Official notice → - 2024-04-17
- US
Qiagen Sciences LLC recalls EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular…
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
FDA · DeviceQiagen Sciences LLCNationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO,…Official notice → - 2023-06-14
- US
Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Faulty cartridges in the lot could result in false test results.
FDA · DeviceQiagen Sciences LLCUS Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.Official notice → - 2022-09-21
- US
Qiagen Sciences LLC recalls QIAcube Connect MDx, Model No. 9003070
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the…
FDA · DeviceQiagen Sciences LLCDomestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN,…Official notice → - 2022-09-07
- US
Qiagen Sciences LLC recalls FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the…
FDA · DeviceQiagen Sciences LLCIN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands,…Official notice → - 2022-04-27
- US
Qiagen Sciences LLC recalls therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
- 2022-01-12
- US
Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
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…
FDA · DeviceQiagen Sciences LLCDomestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign…Official notice →