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For DI Advanced RBC Application

Cellavision AB · Model AB859211 · UDI-DI 07350040974759

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510(k) clearances

Adverse events

Recalls

Facilities

Description

When implemented together with DI-60 and software, the Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics

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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Data 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.