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Coulter LH 780 Hematology Analyzer

by Beckman Coulter, Inc.

510(k) K061616

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK061616 Date4 Oct 2006ClearedStatusActive

Recalls

7 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2481-2015 FDA Class II initiated 22 Jul 2015 on shared 510(k) K061616
    • Terminated Z-2480-2015 FDA Class II initiated 22 Jul 2015 on shared 510(k) K061616

    Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.

    • Terminated Z-0471-2014 FDA Class II initiated 8 Nov 2013

    Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.

    • Terminated Z-0113-2014 FDA Class II initiated 24 Sep 2013

    The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line.

    • Terminated Z-1241-2012 FDA Unclassified (pre-2012) initiated 1 Dec 2011

    The recall was initiated because Beckman Coulter has confirmed that the Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the 2D Barcode scanner.

    • Terminated Z-1954-2011 FDA Unclassified (pre-2012) initiated 31 Jan 2011

    This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will transmit as a blank field to the LIS if the year is greater than 2010. The following dates are affected: Run date, Control expiration date, Date of birth (For individuals born in 2011 or later), a

    • Terminated Z-0313-2008 FDA Unclassified (pre-2012) initiated 18 Apr 2007

    Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- When manually entering a Patient ID, if a blank space is entered between th

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
GKZ
Device Class
Class II
Regulation
21 CFR Part 864.5220
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Coulter LH 780 Hematology Analyzer is a Counter, Differential Cell device designed for automated hematological analysis. It performs complete blood counts, including red blood cell, white blood cell, and platelet measurements, with integrated nucleated red blood cell (NRBC) enumeration for precise differential analysis.

This analyzer is intended for use in clinical laboratories and is supplied as a reusable, non-sterile instrument. It operates under FDA 510(k) clearance (K061616) as substantially equivalent to predicate devices, adhering to regulatory standards for hematology testing. The device requires proper calibration, maintenance, and storage as per manufacturer guidelines to ensure accurate and reliable performance.

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