Sysmex America, Inc. The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt.

Recommended Action

Per FDA guidance

Sysmex America, Inc. notified customers on 03/09/2020 via "Product Notification SP-50 and CF-70 Software Mismatch Field Correction" letter. The recall letter identified the affected product and model numbers. The customers were asked to verify the software version. If the versions did not match, a service visit is required for the correction of the software mismatch.