Recall – Software mismatch causes error condition

Company: Sysmex America, Inc.
Date of Enforcement Report: 4/22/2020
Class II

PRODUCT

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 Number: Z-1703-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Sysmex America, Inc. on 3/9/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

93 units

DISTRIBUTION

US Nationwide

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