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CellaVision® Remote Review Software, Team Edition, version independent
Cellavision AB · Model CRRS-TE0099 · UDI-DI 07350040975909
JOY
Prescription
1
510(k) clearances
18
Adverse events
4
Recalls
10
Facilities
Description
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
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.