Sysmex America, Inc. recalls The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smear…

Recall date

March 9, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1703-2020

FDA classification

Class II

Brand / firm

Sysmex America, Inc.

Sold / distributed

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..

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.