Recall Z-1703-2020 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Sysmex America, Inc.
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.
| Date | Mar 9, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Sysmex America, Inc. notified customers on 03/09/2020 via "Product Notification SP-50 and CF-70 Software Mismatch Field Correction" letter. The recall letter identified the affected product and model numbers. The customers were asked to verify the software version. If the versions did not match, a service visit is required for the correction of the software mismatch. |
| Quantity | 93 units. |
| 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.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.