Z-0039-04

Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604

Name: Z-0039-04 Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604
Creator: Beckman Coulter Inc
Published: 2003-09-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-09-08 / Terminated

FDA source

Beckman Coulter Inc began a recall of Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604 on 2003-09-08. The reason FDA records is "Samples with high fat content will not count platelets accurately". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0039-04
Status: Terminated
Initiated: 2003-09-08
Posted: 2003-10-15
Terminated: 2004-03-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604
Product code: GKZ Counter, Differential Cell
Reason for recall: Samples with high fat content will not count platelets accurately.
FDA root cause: Other
Action: Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.
Quantity in commerce: 36
Distribution: United States and Canada
Product codes and lots: All instruements are affected.

Product code GKZ

K992511Class IIAbx Pentra 60 Hematology AnalyzerAbx Diagnostics / cleared 1999-10-15

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)