Z-1956-2011

Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte...

Name: Z-1956-2011 Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte...
Creator: Beckman Coulter Inc.
Published: 2011-01-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-01-31 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use... on 2011-01-31. The reason FDA records is "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...". 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-1956-2011
Status: Terminated
Initiated: 2011-01-31
Posted: 2011-04-12
Terminated: 2012-09-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter GEN's 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 LH500 Analyzer also provides a semi-automated reticulocyte analysis.
Product code: GKL Counter, Cell, Automated (Particle Counter)
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: The firm, Beckman Coulter, sent an "URGENT: PRODUCTION CORRECTION" letter dated January 31, 2011 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Coulter LH 750 Analyzer, Coulter LH 780 Analyzer, Coulter LH 500 Series System, and Coulter GEN S System. The letter describes the product, problem and actions to be taken. The customers were instructed to work with their US vendor to assess how this affects their laboratory. The actions they choose are dependent on the configuration of their LIS. ACTION FOR ISSUE 1: Use Sample Drawn Date and Date of Birth information available at your LIS in lieu of the analyzer transmitted fields BIRTH and UDATE. Use the current date when the results are received at the LIS in lieu of the transmitted Run Date [DATE]. Print results from the Workstation to keep a copy of the analysis date on the analyzer, if necessary. Use the control expiration date from the analyzer display or printout. ACTION FOR ISSUE 2: If you use the LIS 1G1 transmission format, use the General Information group field names in place of the Retic Parameter group field names to identify each reticulocyte run (see Table in Issue 2 section). Check with your LIS vendor to determine if it is possible to switch to the LH 750 Workstation transmission format. Format requirements are LIS driver specific. For patients with Dates of Birth in 2011 for both Issue 1 and Issue 2, results should be reviewed to determine if decision rules or age-related limits sets were triggered inappropriately. RESOLUTION These issues will be corrected in a future software release for the LH Series products. The GENS product has been discontinued; no software revisions will be forthcoming for the GENS product line. Customers were also instructed to complete and return the PRODUCT CORRECTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 310B06, 11
Quantity in commerce: 9419 (total units distributed in U.S. & foreign countries)
Distribution: Worldwide distribution: USA (nationwide) and countries including: Algeria, Andorra, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Monaco, Morrocco, Myanmar, Namibia, Netherlands, 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, Vietnam, and Virgin Islands (US).
Product codes and lots: part number: 6605381, 6605381R, 6605381U

Product code GKL

K962988Class IICoulter Gen-S SystemCoulter Corp. / cleared 1996-10-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)