Z-0475-06

COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R...

Name: Z-0475-06 COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R...
Creator: Beckman Coulter Inc
Published: 2005-12-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-12-15 / Terminated

FDA source

Beckman Coulter Inc began a recall of COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R on 2005-12-15. The reason FDA records is "There is a risk of sample misidentification when processing samples in the Manual aspiration mode". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0475-06
Status: Terminated
Initiated: 2005-12-15
Posted: 2006-02-04
Terminated: 2012-01-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R
Product code: GKJ Spinner, Slide, Automated
Reason for recall: There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
FDA root cause: Other
Action: A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail)
Quantity in commerce: 1134
Distribution: Nationwide and Canada
Product codes and lots: PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R All Software Versions

Product code GKJ

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)