Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,069–1,080 of 2,908 recalls
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Measles IgM Test Kit lacks premarket approval or clearance.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Dipstick strep A test has potential for false positive results.
Replacement of the internal Sample Pump due to high failure rates.
Software issue that results in the display of outdated information.
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.