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KIRO Link
KIRO GRIFOLS SL. · Model 1006 · UDI-DI 08437014572308
1
510(k) clearances
2,980
Adverse events (10 deaths)
24
Recalls
315
Facilities
Description
KIRO Link is a software intended to enter, store, convert, transfer and display the data to support the integration and workflow management functionalities of Pharmacy Compounding Devices (PCDs) with customer site softwares such as Computerized Physician Order Entry (CPOE), logistics, quality control and compounding assisting software. KIRO Link is intended to be used only by qualified pharmacy personnel.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-08 | Radiometer Medical ApS | Due to potential software issue that may result in patient mix-up information. |
| 2023-02-06 | Biomerieux Inc | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST r |
| 2021-09-02 | BioMerieux SA | Under certain conditions, there is a risk for a false negative result. |
| 2020-09-22 | Pentax of America Inc | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does |
| 2020-09-22 | Pentax of America Inc | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does |
| 2020-01-17 | Beckman Coulter Inc. | A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that |
| 2019-09-25 | ENDOTRONIX | The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix. |
| 2019-08-08 | Radiometer Medical ApS | The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some thir |
| 2019-05-20 | Opternative Inc | Lack of 510K clearance |
| 2017-12-06 | Intel-GE Care Innovations LLC | It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the back |
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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.