Class I - Dangerous
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
🔬
Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
BD Biosciences, Systems & Reagents
Class I - Dangerous
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
Siemens Medical Solutions USA
Class I - Dangerous
There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.
Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
Class I - Dangerous
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Abbott Molecular
Class I - Dangerous
The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases.
Class I - Dangerous
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.
Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
Class I - Dangerous
Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
St Jude Medical Cardiac Rhythm Management Division
Class I - Dangerous
Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
Class I - Dangerous
The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Siemens Medical Solutions USA
Class I - Dangerous
There is a potential for patient finger injury on the e.cam systems.
Diagnostic Imaging Tray (General Surgery convenience kit)
Centurion Medical Products
Class I - Dangerous
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Class I - Dangerous
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.