Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–8 of 8 recalls
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications.…
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Due to the likely presence of contamination in well(s).
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample…
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts.…
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts.…