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X100HT System
SCOPIO LABS LTD · Model SC-SYS-00017 · UDI-DI 07290118610892
3
510(k) clearances
18
Adverse events
4
Recalls
10
Facilities
Description
X100HT with Processing Unit and a Maintenance Kit. Includes: - X100HT Scanner - X100HT Processing Unit - X100HT User Maintenance Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-08 | Cellavision AB | Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. |
| 2018-05-07 | Roche Diagnostics Hematology | Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalassemia) and the following parameters are affected: RBC (red blood cell co |
| 2017-12-04 | Cellavision AB | A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides |
| 2016-05-02 | Leica Biosystems Richmond Inc. | Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These |
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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.