Complete FDA and NHTSA recall records dated in May 2019.
These records include useful source details for the selected month.
There is a potential of fracture, bending or shearing of the driver.
There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
There were multiple issues identified in the system software which required an update.
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g.…
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
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
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…
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
There were multiple issues identified in the system software which required an update.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
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
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
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.
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…
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
There is a potential of fracture, bending or shearing of the driver.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
