FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1703-2020
- Recalling firm
- Sysmex America, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-03-09
- Posted
- not on file
- Terminated
- 2021-03-24
- 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..
- Lot, serial or model codes
- Catalog No. AH699752.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXG
- Firm FEI
- 3009711478
- Firm city
- Lincolnshire
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06