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Leica Biosystems CytoVision GSL10 scanning sys for Karyotyping&FISH
Leica Biosystems Richmond, Inc. · Model 23GSL10XKFX001 · UDI-DI 00849832003304
JOY
Prescription
10
510(k) clearances
18
Adverse events
4
Recalls
10
Facilities
Description
Leica Biosystems CytoVision GSL10 scanning sys for Karyotyping &FISH
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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