CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report

The CF-70 instrument (product recalled by Sysmex America

Sysmex America is recalling The CF-70 instrument (product, distributed nationwide in the US. The recall was initiated on 9 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog No. AH699752.

Quantity recalled93 units.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1703-2020
FDA event ID: 85254
Recalling firm: Sysmex America, Lincolnshire, IL
Classification: Class II
Status: Terminated
Recall initiated: 9 Mar 2020
FDA classified: 14 Apr 2020
Reported: 22 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

9 Mar 2020	Recall initiated by company
14 Apr 2020	Classified by FDA	+36 days
22 Apr 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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..

Nationwide Alaska Arkansas Arizona California Colorado Connecticut Delaware Florida Illinois Kentucky Louisiana Massachusetts Maryland Michigan Missouri Mississippi Montana North Carolina New Jersey New Mexico

Questions about this recall

Is The CF-70 instrument (product recalled?

Yes. Sysmex America recalled The CF-70 instrument (product on 9 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-1703-2020.

Why was it recalled?

Which lots are affected?

Catalog No. AH699752.

Where was it sold?

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..

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Sysmex America

All 14

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	TS-10/TS-10H Tube Sorter, automatic sorting system recalled	Sysmex America	Device Malfunction	Nationwide
12 Feb 2025Device	CLASS II	Sysmex PS-10 Sample Preparation System recalled by Sysmex America	Sysmex America	Device Malfunction	Nationwide
29 Jul 2020Device	CLASS II	Sysmex PS-10 Sample Preparation System recalled by Sysmex America	Sysmex America	Device Malfunction	Nationwide
22 Apr 2020Device	CLASS II	Sysmex CV-11 Sample Unit, an integrated modular sampler recalled	Sysmex America	Other	FL, IL, VT
5 Sep 2018Device	CLASS II	Sysmex XN-Series Fluorocell PLT recalled by Sysmex America	Sysmex America	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide