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LabPro Data Management System

by Beckman Coulter, Inc.

510(k) K201405

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201405 Date30 Aug 2020ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2888-2026 FDA Class II initiated 26 Jun 2026
    • Ongoing Z-2889-2026 FDA Class II initiated 26 Jun 2026

    Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LON
Device class
Class II
Regulation
21 CFR Part 866.1645
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

LabPro Data Management System is a Microsoft Windows based software program intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results. It aggregates microbial identification (ID) and antimicrobial susceptibility testing (AST) data from Beckman Coulter instruments, manual entry, or third-party systems.

The system is designed for use by trained laboratory personnel in clinical microbiology laboratories. It includes two functional modules: LabPro AlertEx, which applies rule-based logic to ID/AST data. The device is supplied as a software system and is regulated under FDA 510(k) clearance K201405 with product code LON and regulation number 866.1645.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the LabPro Data Management System intended to do?

    The LabPro Data Management System is intended to manage microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results, aggregating data from instruments, manual entry, or third-party systems.

  • Who is the LabPro Data Management System designed for?

    The system is designed for use by trained laboratory personnel in clinical microbiology laboratories, as it requires training to operate its functional modules, including LabPro AlertEx, which applies rule-based logic to ID/AST data.

  • How is the LabPro Data Management System supplied and what type of device is it?

    The LabPro Data Management System is supplied as a software system and is a Microsoft Windows based program, meaning it is delivered electronically or via installable media for use on compatible Windows operating systems in laboratory settings.

  • What regulatory pathway was used for the LabPro Data Management System?

    The device was regulated under FDA 510(k) clearance K201405, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) submission process.