Z-1703-2020Class II

The CF-70 instrument (

Name: Z-1703-2020 The CF-70 instrument (
Creator: Sysmex America, Inc.
Published: 2020-03-09
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2020-03-09 / Terminated / root cause: software

FDA source

Sysmex America, Inc. began a recall of The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that... on 2020-03-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1703-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-09
Posted: 2020-04-14
Terminated: 2021-03-24
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.
Product code: LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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.
Root cause tag: software
FDA 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 in commerce: 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..
Product codes and lots: Catalog No. AH699752.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1703-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1703-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-14

Product code LXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)