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Pointe Scientific, Inc. ISE Internal Reference

HORIBA INSTRUMENTS INCORPORATED · Model HI790-REF · UDI-DI 00811727014757

JGS Prescription

510(k) clearances

3,993

Adverse events (3 deaths)

Recalls

Facilities

Description

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. 6 x 2L

Recalls

Date	Firm	Reason
2025-07-07	Siemens Healthcare Diagnostics Inc	Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed ave
2023-09-26	Siemens Healthcare Diagnostics Inc	There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPID
2023-09-26	Siemens Healthcare Diagnostics Inc	There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPID
2023-09-18	Nova Biomedical Corporation	Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the fir
2023-09-18	Nova Biomedical Corporation	Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the fir
2021-11-18	Siemens Healthcare Diagnostics, Inc.	(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magni
2021-05-18	Siemens Healthcare Diagnostics, Inc.	ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure det
2021-05-13	Siemens Healthcare Diagnostics, Inc.	Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and
2021-05-04	Siemens Healthcare Diagnostics, Inc.	Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
2020-12-02	Siemens Healthcare Diagnostics, Inc.	Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

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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.