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I.S.E. K
RANDOX LABORATORIES LIMITED · Model D400-0012 · UDI-DI 05055273214864
CEM
Prescription
10
510(k) clearances
1,010
Adverse events (4 deaths)
63
Recalls
82
Facilities
Description
Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-31 | Medica Corporation | A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary |
| 2025-10-30 | Inpeco S.A. | The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs |
| 2025-10-30 | Inpeco S.A. | The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occur |
| 2025-09-03 | Inpeco S.A. | The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluate |
| 2025-09-03 | Inpeco S.A. | The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated |
| 2023-11-03 | Inpeco S.A. | Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing. |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may |
| 2023-03-10 | Inpeco S.A. | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decre |
| 2023-03-10 | Inpeco S.A. | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decre |
| 2023-03-10 | Inpeco S.A. | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decre |
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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.