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Pointe Scientific
HORIBA INSTRUMENTS INCORPORATED · Model HI790-STL · UDI-DI 00811727012425
JGS
Prescription
1
510(k) clearances
3,993
Adverse events (3 deaths)
48
Recalls
85
Facilities
Description
ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes. packaged at 10 x 2ml
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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Get your free API keyRead the docsData 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.