# FDA recall Z-1703-2020

> **Sysmex America, Inc.** · Class II · device recall initiated 2020-03-09.

## 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.

## 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.

## Distribution

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..

## Key facts

- **Recall number:** Z-1703-2020
- **Recalling firm:** Sysmex America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-09
- **Report date:** 2020-04-22
- **Termination date:** 2021-03-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lincolnshire, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1703-2020

## Citation

> AI Analytics. FDA recall Z-1703-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1703-2020. Source: US FDA. Licensed CC0.

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