Medical equipment, implants, and diagnostic devices
Bard Peripheral Vascular
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
Beckman Coulter
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
CareFusion 303
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
Beckman Coulter
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
Deroyal Industries, Inc. Lafollette
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Baxter Healthcare
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.
Roche Diagnostics Operations
The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.
CareFusion 303
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen.
It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become unstable and tip over, potentially leading to the scale falling from the cart. If a baby is left unattended in a cart, the baby could fall off the scale and be subjected to several serious injuries.
Beckman Coulter
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
Tosoh Bioscience
A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.
Biofire Defense
The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.
CareFusion 303
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders