FDAAugust 28, 2024device
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormon...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
What to do
FDA enforcement status: Ongoing
Brands named
beckman coulterbeckman
UPCs
15099590744373
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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