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.
Read the official notice →- Date
- 2022-04-27
- Country
- United States
- Brand
- Qiagen Sciences
- Product
- therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
- Classification
- Class II
- Units
- AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Qiagen Sciences recalls
- 2024-07-24
USQiagen 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 → - 2022-01-12
- 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 →
Other drugs & medical recalls in the United States
- 2022-04-27
- US
Abbott recalls Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
FDA · DeviceAbbottWorldwide distribution - US Nationwide - there was government distribution but…Official notice → - US
Microbiologics Inc recalls Inactivated macrolide-resistant Mycoplasma genitalium
The QC process was not adequate for the specification range.
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of NV and VT.Official notice → - US
Microbiologics Inc recalls Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
QC process was not adequate for the specification range.
- US
Resource Optimization & Innovation LLC recalls Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
A kit component, the PDI Prevantics Swab, was recalled.
FDA · DeviceResource Optimization & Innovation LLCUS distribution to two consignees located in MissouriOfficial notice → - US
Terumo Cardiovascular Systems Corp recalls Cardiovascular Procedure Kit catalog # 76645 & 73806
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
FDA · DeviceTerumo Cardiovascular Systems CorpUS Nationwide distribution in the states of CA and IN.Official notice → - US
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Product is mislabeled as self-righting Luer slip tip caps, yellow.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution in the states of FL, GA,…Official notice →