The FDA has posted 8 enforcement recalls from Beckman Coulter, Inc. since 2025, none of them Class I (most serious). Most recent report: Apr 29, 2026.
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 a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Due to the likely presence of contamination in well(s).
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
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…
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.…
Firm name as filed with the FDA: “Beckman Coulter, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.