SmartLyte Electrolyte Analyzer
Diamond Diagnostics Inc. · Model 0-DD-SMARTLYTE · UDI-DI 00811403019892
Description
SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. It is microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness.
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 System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated |
| 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 |
| 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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