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Sysmex America, Inc. recalls The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears
Recalled April 22, 2020 · FDA recall Z-1703-2020 · Sysmex America
Hazard
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. · FDA Class II
Units
93 units.
Sold at
USA nationwide distribution in the states of AK, AR, AZ, CA, CO, CT, DE, FL, IL, KY, LA, MA, MD, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, TN, TZ, UT and WA..
Description
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.
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.
Manufacturer(s)
Sysmex America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →