Coulter Lh 500 Hematology Analyzer

• • Terminated Z-1243-2012 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-0599-2012 FDA Unclassified (pre-2012) ·initiated 13 Oct 2011

  The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.

• • Terminated Z-2042-2011 FDA Unclassified (pre-2012) ·initiated 2 Mar 2011

  The recall was initiated because Beckman Coulter has identified a problem with Integrated Circuit Chips used in different boards throughout the Beckman Coulter LH500/HmX/HmX Autoloader Hematology analyzer.

• • Terminated Z-1955-2011 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-2337-2010 FDA Unclassified (pre-2012) ·initiated 12 Feb 2010

  The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu

• • Terminated Z-1657-2010 FDA Unclassified (pre-2012) ·initiated 4 Feb 2010

  Issue 1: The system will substitute or omit the characters # @ [\] ' {I) when the system is configured in a language other than English or Chinese. Example: Using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456' Issue 2: The system will omit the character ~ regardless of language. Impact: There is a potential for Specimen

• • Terminated Z-0314-2008 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-1245-06 FDA Unclassified (pre-2012) ·initiated 17 Apr 2006 ·on shared 510(k) K032000

  Beckman has confirmed that erroneous results could be reported when the workstation database crashes.

• • Terminated Z-1433-04 FDA Unclassified (pre-2012) ·initiated 12 Aug 2004

  Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an incorrect dilution factor with a predilute sample result.

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

510(k) Number

K032000 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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