Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 313–324 of 386 recalls
DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline s…
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
The RSV target may give a late Ct value and could potentially not pass QC.
Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper.…
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor.…
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer E…
Due to fingerprint scanner failing resulting in the scanner heating up.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.