CLASS II Device recall · Reported 29 Jul 2020 · 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 Jul 2020 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-2687-2020
- FDA event ID
- 85959
- Recalling firm
- Sysmex America, Lincolnshire, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jul 2020
- FDA classified
- 22 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Jul 2020 | Recall initiated by company | |
| 22 Jul 2020 | Classified by FDA | +16 days |
| 29 Jul 2020 | 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
Insufficient amount of antibody without an error message or alarm
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 Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
Where it was distributed
US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
Questions about this recall
Why was it recalled?
Insufficient amount of antibody without an error message or alarm
Which lots are affected?
Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966
Where was it sold?
US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
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 |
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