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DIRECT HDL-CHOLESTEROL (HDL)

RANDOX LABORATORIES LIMITED · Model CH2655 · UDI-DI 05055273201185

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma.

Recalls

Date	Firm	Reason
2025-12-08	Beckman Coulter Ireland, Inc.	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 sig
2017-04-03	Beckman Coulter Inc.	Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results
2016-08-02	Alere San Diego, Inc.	Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
2016-03-17	Siemens Healthcare Diagnostics, Inc.	Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirm
2015-05-07	Roche Diagnostics Operations, Inc.	Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine
2015-05-07	Roche Diagnostics Operations, Inc.	Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine
2013-06-12	Ortho-Clinical Diagnostics	Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
2012-02-02	Ortho-Clinical Diagnostics	Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type.
2008-06-11	Roche Diagnostics Corp.	Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.