Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1703-2020

March 09, 2020

Class II

Product summary

Firm
Sysmex America, Inc.
Event
Event 85254
Status
Terminated
Classification
Class II
Quantity
93 units.
Official record key
device-enforcement:Z-1703-2020

Official wording

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.

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..

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.