Sample Preparation System PS-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987562501908), received between Jan 9, 2025 and Feb 6, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 6, 2025Open, Classified

   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.

   Z-1113-2025 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Computer Software Problem; Computer Software Problem

  A SOFTWARE DEFECT WAS IDENTIFIED IN SAMPLE PREPARATION SYSTEM PS-10 SERIAL NUMBER (SN) (B)(6) SOFTWARE VERSION 1.5, WHERE OMISSION OF THE PROBE WASH STEP AND POTENTIAL ANTIBODY CARRY-OVER MAY LEAD TO POSSIBLE ERRONEOUS REPRESENTATION OF ANTIGEN MARKERS IN A SAMPLE AND THUS GENERATE ERRONEOUS RESULTS IN SUBSEQUENT FLOW CYTOMETRY ANALYSIS. THERE HAS BEEN NO REPORT OF INCORRECT TREATMENT, SERIOUS INJURY OR DEATH DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322948 ↗
• MalfunctionJan 10, 2025Computer Software Problem; Computer Software Problem

  A SOFTWARE DEFECT WAS IDENTIFIED IN SAMPLE PREPARATION SYSTEM PS-10 SOFTWARE VERSION 1.5 AND SOFTWARE VERSION 1.6, WHERE OMISSION OF THE PROBE WASH STEP AND POTENTIAL ANTIBODY CARRY-OVER MAY LEAD TO POSSIBLE ERRONEOUS REPRESENTATION OF ANTIGEN MARKERS IN A SAMPLE AND THUS GENERATE ERRONEOUS RESULTS IN SUBSEQUENT FLOW CYTOMETRY ANALYSIS. THERE HAS BEEN NO REPORT OF INCORRECT TREATMENT, SERIOUS INJURY OR DEATH DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130098 ↗
• MalfunctionJan 9, 2025Computer Software Problem; Computer Software Problem

  A SOFTWARE DEFECT WAS IDENTIFIED IN SAMPLE PREPARATION SYSTEM PS-10 SOFTWARE VERSION 1.5 AND SOFTWARE VERSION 1.6, WHERE OMISSION OF THE PROBE WASH STEP AND POTENTIAL ANTIBODY CARRY-OVER MAY LEAD TO POSSIBLE ERRONEOUS REPRESENTATION OF ANTIGEN MARKERS IN A SAMPLE AND THUS GENERATE ERRONEOUS RESULTS IN SUBSEQUENT FLOW CYTOMETRY ANALYSIS. THERE HAS BEEN NO REPORT OF INCORRECT TREATMENT, SERIOUS INJURY OR DEATH DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111764 ↗