Recall Z-1703-2020— Sysmex America, Inc.
Class II · Terminated
Class II FDA medical device recall by Sysmex America, Inc., initiated 2020-03-09, terminated 2021-03-24. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Sysmex America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-09
- Terminated
- 2021-03-24
- Firm location
- Lincolnshire, IL, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.