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Pointe Scientific, Inc.

HORIBA INSTRUMENTS INCORPORATED · Model HI790-DIL · UDI-DI 00811727012722

CGZ JGS Prescription

510(k) clearances

158

Adverse events

Recalls

Facilities

Description

ISE Diluent, for the quantitative determination of sodium, potassium, and chloride in serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Size: 6 x 2L

Recalls

Date	Firm	Reason
2019-09-10	Ortho-Clinical Diagnostics	Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
2019-09-10	Ortho-Clinical Diagnostics	Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
2018-08-28	Abbott Laboratories, Inc	There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
2018-07-11	Ortho-Clinical Diagnostics	The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observ
2018-07-11	Ortho-Clinical Diagnostics	The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L)
2011-03-15	OPTI Medical Systems, Inc	The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma
2009-04-20	OPTI Medical Systems, Inc	Outer box labeling shows an incorrect storage temperature range.
2008-05-23	Abbott Laboratories, Inc	Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.
2007-09-26	Abbott Laboratories, Inc	Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the in
2005-02-01	Radiometer America Inc	The CI membrane units generate too low values for status and sensitivity during calibration.

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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.