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…
Read the official notice →- Date
- 2022-09-21
- Country
- United States
- Brand
- Qiagen Sciences
- Product
- QIAcube Connect MDx, Model No. 9003070
- Classification
- Class II
- Units
- Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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 →- 2022-09-07
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 →
Other drugs & medical recalls in the United States
- 2022-09-21
US
Alcor Scientific, Inc. recalls iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the…
Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR Analyzer, there is a potential of a biohazard leak from the iSEDs Probe Tube
FDA · DeviceAlcor Scientific, Inc.US Nationwide Distribution - FL, MA, MD, PA, SD, WI Foreign: Croatia Honduras…Official notice →US
FUJIFILM Healthcare Americas Corporation recalls Surpria 64: Software Version V3.11, V3.22
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to…
US
Carwild Corporation recalls FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number:…
Sterility with new cotton source not validated
US
Mallinckrodt, LLC. recalls INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient…
The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was…
FDA · DeviceMallinckrodt, LLC.Foreign Only: Argentina Australia Austria Beligum Canada Chile Columbia Czech…Official notice →US
Philips Medical Systems (Cleveland) Inc recalls Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
FDA · DevicePhilips Medical Systems (Cleveland) IncDistribution was made to CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV,…Official notice →US
Aniara Diagnostica LLC recalls BIOPHEN UFH Control Plasma
Incorrect product labeling was included in the package.