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BECKMAN COULTER IRELAND INC.

Ireland IE-MF-000000887 Last updated 25 May 2026

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Devices
144
Registries
EUDAMEDFDA 510(k)GUDID
FDA recalls
33 ongoing

Catalogue144

Page 1 of 3

Showing 1-50 of 144

FDA recalls3

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2025

    • 8 Dec 2025 Z-1135-2026 Class II Ongoing 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).
    • 14 Oct 2025 Z-0997-2026 Class II Ongoing Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
    • 23 Apr 2025 Z-1815-2025 Class III Ongoing 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.

Information

Country
Ireland
Address
Lismeehan, Co. Clare, Ireland
Phone
+353 65 6831100
PRRC contact
Marguerita Sweeney
EUDAMED SRN
IE-MF-000000887
DUNS number
985071975