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Recall Observatory FDA recall evidence

Device product

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.

Z-2687-2020

July 06, 2020

Class II

Product summary

Firm
Sysmex America, Inc.
Event
Event 85959
Status
Terminated
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-2687-2020

Official wording

Reason: Insufficient amount of antibody without an error message or alarm

Code information: Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966

Distribution pattern: US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Insufficient amount of antibody without an error message or alarm