Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Ortho-Clinical Diagnostics
Class I - Dangerous
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Cardinal Health 200
Class I - Dangerous
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Class I - Dangerous
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
There is a potential of fracture, bending or shearing of the driver.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Cardinal Health 200
Class I - Dangerous
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Cardinal Health 200
Class I - Dangerous
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Class I - Dangerous
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
Alpha Omega Engineering
Class I - Dangerous
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Class I - Dangerous
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Atellica IM 1600 Analyzer, Material Number 11066000
Siemens Healthcare Diagnostics
Class I - Dangerous
There were multiple issues identified in the system software which required an update.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Class I - Dangerous
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Class I - Dangerous
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Class I - Dangerous
The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.