Reported Feb 12, 2025 · Ongoing
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for…
Sysmex America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sysmex America, Inc. · 577 Aptakisic Rd · Lincolnshire, IL · 60069-4325
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI04987562501908
- Serial Numbers
19080022751908002276190800977519100095881910011295191200263821030139132108004629210800463021080046312108004632211200542321120054252203014206220301420722030142082205012732220501273422060059732206012294220801583522100037222210003723221000372422120100481903011966190301196819100095891912002640210301391222080158341903011967
- Amount recalled
- 32 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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