FDAOctober 24, 2016device
Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.
What to do
FDA enforcement status: Terminated
Brands named
beckman coulterbeckman
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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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