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I.S.E. REF

RANDOX LABORATORIES LIMITED · Model D200-0017 · UDI-DI 05055273210552

JGSCEMCGZ Prescription
10
510(k) clearances
3,993
Adverse events (3 deaths)
48
Recalls
85
Facilities

Description

Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.

Recalls

DateFirmReason
2025-07-07Siemens Healthcare Diagnostics IncSiemens 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
2023-09-26Siemens Healthcare Diagnostics IncThere are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPID
2023-09-26Siemens Healthcare Diagnostics IncThere are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPID
2023-09-18Nova Biomedical CorporationPotential 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
2023-09-18Nova Biomedical CorporationPotential 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
2021-11-18Siemens 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
2021-05-18Siemens 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
2021-05-13Siemens 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
2021-05-04Siemens Healthcare Diagnostics, Inc.Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
2020-12-02Siemens 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.