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Pointe Scientific, Inc. Triglyceride

HORIBA INSTRUMENTS INCORPORATED · Model OT932-780 · UDI-DI 00811727015129

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Pointe Scientific, Inc. Triglyceride Reagent is for the in vitro quantitative determination of Triglycerides in serum or plasma. Packaged for use on Olympus Analyzers. 12 x 65ml

Recalls

Date	Firm	Reason
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
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
2021-10-06	Siemens Healthcare Diagnostics, Inc.	The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association
2019-08-15	Beckman Coulter Inc	It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quanti
2018-08-24	Beckman Coulter Inc.	NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
2018-03-02	Randox Laboratories Ltd.	Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
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
2016-08-11	Ortho-Clinical Diagnostics	Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere wit
2016-08-02	Randox Laboratories Ltd.	According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to amend the running o
2016-04-13	Beckman Coulter Inc.	Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6

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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.