Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury