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…
Read the official notice →- Date
- 2022-09-07
- Country
- United States
- Brand
- Qiagen Sciences
- Product
- FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
- Classification
- Class II
- Units
- IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 → - 2022-04-27
- 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 →
Other drugs & medical recalls in the United States
- 2022-09-07
- US
Corin Ltd recalls TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Some of the devices did not pass fatigue testing.
FDA · DeviceCorin LtdDistribution was made to NJ. There was no military/government distribution.Official notice → - US
Canon Medical System, USA, INC. recalls INFX-8000V. For radiographic and fluoroscopic studies and intervention.
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
- US
Abbott Laboratories recalls ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
- US
New Standard Device Inc recalls Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin…
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
FDA · DeviceNew Standard Device IncU.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: NoneOfficial notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.…
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Austria,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide Distribution: US (nationwide) and OUS (Foreign) to countries of:…Official notice →