Sysmex recalls PS-10 Sample Preparation System with software versions 1.5 and 1.6 due to false test results from occasional probe wash step omissions during antibody pipetting.
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.
Sysmex is recalling its PS-10 Sample Preparation System with software versions 1.5 and 1.6 because it can produce false test results if the probe wash step is occasionally skipped during antibody pipetting. This affects laboratory equipment used for flow cytometric analysis and could lead to incorrect medical test outcomes.
The system occasionally skips the probe wash step during antibody pipetting, which can cause false test results. This happens because the software versions 1.5 and 1.6 have a defect that leads to the omission of this critical step in the testing process.
Laboratories using the Sysmex PS-10 Sample Preparation System with software versions 1.5 or 1.6 are affected. Lab technicians and medical professionals who rely on this equipment for blood testing are most at risk of receiving inaccurate results.
Check for the Sysmex PS-10 Sample Preparation System with software versions 1.5 or 1.6. The product has a catalog number BQ716341 and specific serial numbers listed in the recall notice.
Verify your PS-10 system's software version is 1.5 or 1.6 by checking the device settings or documentation.
Reach out to Sysmex America, Inc. for guidance on whether your system needs correction or if a software update is available.
Sysmex was made aware of reports of false test results due to the occasional omission of the probe wash step during antibody pipetting on the PS-10 system with software versions 1.5 and 1.6.
Check your software version and contact Sysmex America, Inc. for instructions on whether a software update or other remedy is needed.
The recall is for potential false test results, not physical injury. There is no risk of injury from this product.
We’ve drafted a message you can send Sysmex to request your refund or repair — edit it as you like.
Subject: Recall Z-1113-2025 — Sysmex Sysmex Hello, I own a Sysmex that is covered by recall Z-1113-2025 from Sysmex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
