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Synermed®
INFRARED LABORATORY SYSTEMS LLC · Model ISE800 · UDI-DI 05060500091071
1
510(k) clearances
1,008
Adverse events (4 deaths)
63
Recalls
82
Facilities
Description
Olympus ISE Buffer 6 X 1000 mL
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.