Z-0315-2008

COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)

Name: Z-0315-2008 COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)
Creator: Beckman Coulter Inc
Published: 2007-04-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-04-18 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer) on 2007-04-18. The reason FDA records is "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...". 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-0315-2008
Status: Terminated
Initiated: 2007-04-18
Posted: 2007-12-22
Terminated: 2012-04-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)
Product code: GKL Counter, Cell, Automated (Particle Counter)
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: Product Corrective Action (PCA) letters were mailed on April 18,2007, to all GENS, LH500, LH750 and LH780 accounts. They are informed that a potential misidentification can occur in 2 scenarios. 1. When a positive identifier (Sample ID or CassetteIPosition) is manually edited to a positive identifier that is already in the ToDo 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 the characters in the Patient ID field, the system will only accept the characters before the space.----Short term fix----- The letter explains the issues and provides the customer work around. (Letters were sent by US mail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.
Quantity in commerce: 815 units to the US; 95 units to Canada
Distribution: World wide: USA and Canada
Product codes and lots: Part Number 6605381. All software versions

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)