Coulter Lh 750 Hematology Analyzer, Model 6605632

• • Terminated Z-3113-2017 FDA Class II ·initiated 26 Jun 2017

  Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.

• 2 recalls, same reason

  • Terminated Z-2480-2015 FDA Class II ·initiated 22 Jul 2015 ·on shared 510(k) K011342
  • Terminated Z-2481-2015 FDA Class II ·initiated 22 Jul 2015 ·on shared 510(k) K011342

  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-0470-2014 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-1242-2012 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-1953-2011 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-0312-2008 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

• • Terminated Z-0566-2007 FDA Unclassified (pre-2012) ·initiated 12 Sep 2006

  There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.

• • Terminated Z-0474-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005

  There is a risk of sample misidentification when processing samples in the Manual aspiration mode.

• • Terminated Z-0905-04 FDA Unclassified (pre-2012) ·initiated 31 Mar 2004

  If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation.

• • Terminated Z-0541-03 FDA Unclassified (pre-2012) ·initiated 10 Jan 2003

  Biohazard situation exists for users.

• • Terminated Z-0669-03 FDA Unclassified (pre-2012) ·initiated 27 Dec 2002

  Incorrect Hemoglobin result can be reported with software version 2A and higher.

• • Terminated Z-0571-03 FDA Unclassified (pre-2012) ·initiated 10 Dec 2002 ·on shared 510(k) K011342

  Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.

• • Terminated Z-0415-03 FDA Unclassified (pre-2012) ·initiated 8 Nov 2002

  Software vote out logic changed. Erroneous white blood cell counts.

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

510(k) Number

K011342 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Access Testosterone

  Class B

  CE/IVDR

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  Class C

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  Class B

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  Class C

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  IVD Annex II List A

  CE/IVDD

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  Class C

  CE/IVDR

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