FDAApril 30, 2019device
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i syst...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays (Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
What to do
FDA enforcement status: Terminated
Brands named
beckman coulterbeckman
UPCs
15099590227173
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAccess Total T4 Calibrator, Catalog No. 338052026-03-16
- FDACHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B232812026-01-30
- FDADxC 700 AU, REF: B86444, B864462026-01-30
- FDACellMek SPS Sample Preparation System, REF: C44603, with software2025-12-23
- FDAThe LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end prod...2025-12-08
- FDABeckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit2025-11-26
- FDABeckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit2025-11-26
- FDACOULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemake...2025-11-10
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