Z-1243-2012

COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series System 100V, PN...

Name: Z-1243-2012 COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series System 100V, PN...
Creator: Beckman Coulter Inc.
Published: 2011-12-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-12-01 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series System 100V, PN 178832; LH 500 Series System 120V, PN 178833; LH 500... on 2011-12-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1243-2012
Status: Terminated
Initiated: 2011-12-01
Posted: 2012-03-21
Terminated: 2014-09-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series System 100V, PN 178832; LH 500 Series System 120V, PN 178833; LH 500 Series System 240V, PN 178834; LH 500 Series System Remanufactured (115V), PN A91062; LH 500 Series System Remanufactured (220V), PN A90994 SW Version 2A4, 2A5. Serial Number: all. The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH 500 Analyzer also provides a semi-automated reticulocyte analysis.
Product code: GKZ Counter, Differential Cell
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 30, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers who use the Auto-Stop or Auto-Transmit to ensure the settings are enabled in Control Setup after scanning the assay sheets. Additionally, a Response Form was included for customers to complete and return. Contact Beckman Coulter Customer Service at (800) 526-7694 for questions regarding this notice.
Quantity in commerce: 8,922 units total (4,073 units in US)
Distribution: Worldwide Distribution-USA (nationwide) including the Virgin Islands and the countries of Algeria Andorra Angola Antigua and Barbuda Argentina Australia Bahrain Bangladesh Belgium Bermuda Brazil Bulgaria Burundi Cameroon Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Ethiopia France Germany Greece Guadeloupe Guam Guatemala Honduras Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Jordan Korea, Republic of Kuwait Latvia Lebanon Libyan Arab Jamahiriya Lithuania Macao Malaysia Mayotte Mexico Monaco Morocco Myanmar Namibia Netherlands New Zealand Norway Oman Pakistan Panama Philippines Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Trinidad and Tobago Tunisia Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam Yemen Zimbabwe
Product codes and lots: Not available.

Product code GKZ

K032000Class IICoulter Lh 500 Hematology AnalyzerBeckman Coulter, Inc. / cleared 2003-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)