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Mercodia Oxidized LDL ELISA

Mercodia AB · Model 10-1143-01 · UDI-DI 07350108630139

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Recalls

Date	Firm	Reason
2025-09-17	Beckman Coulter Inc.	Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results.
2023-01-27	Siemens Healthcare Diagnostics, Inc.	Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
2018-10-08	Ortho-Clinical Diagnostics	VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
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
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.
2008-05-29	Polymer Technology Systems, Inc.	The expiration date was extended by 20 weeks without justification.
2003-08-15	Beckman Coulter Inc	LDL Cholesterol component in controls are unstable.
2003-02-10	Beckman Coulter Inc	Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.

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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.