Sysmex America, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1703-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 9, 2020

Date Posted: April 22, 2020

Recall Number: Z-1703-2020

Event ID: 85254

Reason for Recall:

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.

Status: Terminated

Product Quantity: 93 units.

Code Information:

Catalog No. AH699752.

Distribution Pattern:

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..

Voluntary or Mandated:

Voluntary: Firm initiated