CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report
Sysmex PS-10 Sample Preparation System recalled by Sysmex America
Sysmex America is recalling Sysmex PS-10 Sample Preparation System, distributed nationwide in the US. The recall was initiated on 6 Jan 2025 and the FDA has classified it as Class II.
Check your package
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-1113-2025
- FDA event ID
- 96107
- Recalling firm
- Sysmex America, Lincolnshire, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jan 2025
- FDA classified
- 5 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 6 Jan 2025 | Recall initiated by company | |
| 5 Feb 2025 | Classified by FDA | +30 days |
| 12 Feb 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
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
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
Which lots are affected?
UDI-DI: 04987562501908; Serial Numbers: 1908002275 1908002276 1908009775 1910009588 1910011295 1912002638 2103013913 2108004629 2108004630 2108004631 2108004632 2112005423 2112005425 2203014206 2203014207 2203014208 2205012732 2205012734 2206005973 2206012294 2208015835 2210003722 2210003723 2210003724 2212010048 1903011966 1903011968 1910009589 1912002640 2103013912 2208015834 1903011967
Where was it sold?
US Nationwide.
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 26 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 |
|---|---|---|---|---|---|
| Device | CLASS II | TS-10/TS-10H Tube Sorter, automatic sorting system recalled | Sysmex America | Device Malfunction | Nationwide |
| Device | CLASS II | Sysmex PS-10 Sample Preparation System recalled by Sysmex America | Sysmex America | Device Malfunction | Nationwide |
| Device | CLASS II | The CF-70 instrument (product recalled by Sysmex America | Sysmex America | Device Malfunction | Nationwide |
| Device | CLASS II | Sysmex CV-11 Sample Unit, an integrated modular sampler recalled | Sysmex America | Other | FL, IL, VT |
| Device | CLASS II | Sysmex XN-Series Fluorocell PLT recalled by Sysmex America | Sysmex America | Other | Nationwide |
Other Medical Software recalls
All 932| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |