Reported Jul 29, 2020 · Terminated

Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user…

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 Catalog numberBQ716341 -
  • Product Usageis a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers
Lot codes and dates
  • Serial Numbers
    • 1906007896
    • 1907014703
    • 1908002274
    • 1908002273
    • 1907014704
    • 1903011967
    • 1903011968
    • 1903011966
Amount recalled
8 units

Where it was sold

Why it was recalled

Insufficient amount of antibody without an error message or alarm

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 21, 2021 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.