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Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
New Flyer of America, Inc. (New Flyer) is recalling certain 2023-2024 XDE60, 2024 XD35, XD40, and XD60 transit buses equipped with Cummins L9 diesel engines. The remote fuel filter hoses may separate from the fitting, causing a fuel leak and an engine stall.
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
Temsa is recalling certain 2024 TS35 vehicles equipped with Cummins L9 diesel engines. The remote fuel filter hoses may separate from the fitting, causing a fuel leak and an engine stall.
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.