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SYSMEX AMERICA INC

SP-50 · Gastroenterology and Urology

510(k): 0 Recall: 1 UDI: 0 MAUDE: 0 Class.: 0

Recalls (1)

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
2020-03-09

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.