The CF-70 instrument — Class II medical device recall Z-1703-2020
Terminated recall by Sysmex America, Inc., reported 2020-04-22, distributed nationwide. Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error conditi
| Recall number | Z-1703-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America, Inc., Lincolnshire, IL, United States |
| Recall initiated | 2020-03-09 |
| Classified | 2020-04-14 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2021-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 93 units |
| Reason classes | software |
| Model numbers | AH699752 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1703-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.