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Beckman Coulter Ireland Recalls
3 recalls on record · June 4, 2025 to January 28, 2026 · Medical Devices
Recalls by year
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 28, 2026Medical DevicesFDA
Beckman Coulter Ireland, Inc. recalls The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol f
Hazard: Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).
December 31, 2025Medical DevicesFDA
Beckman Coulter Ireland, Inc. recalls BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitat
Hazard: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
June 4, 2025Medical DevicesFDA
Beckman Coulter Ireland, Inc. recalls Apo B Reagent, REF: OSR6143
Hazard: The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.