Z-0339-05

ACT diff 2 Analyzer (Automated differential cell counter)

Name: Z-0339-05 ACT diff 2 Analyzer (Automated differential cell counter)
Creator: Beckman Coulter Inc
Published: 2004-12-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-12-03 / Terminated

FDA source

Beckman Coulter Inc began a recall of ACT diff 2 Analyzer (Automated differential cell counter) on 2004-12-03. The reason FDA records is "Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0339-05
Status: Terminated
Initiated: 2004-12-03
Posted: 2004-12-21
Terminated: 2012-01-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ACT diff 2 Analyzer (Automated differential cell counter)
Product code: GKZ Counter, Differential Cell
Reason for recall: Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed.
FDA root cause: Other
Action: A letter issued to users informing them of the incompatability of the Coulter ACT diff 2 Analyzer with the use of Monoject blood collection tubes made by Tyco Healthcare Group/Kendall Healthcare. Customers choosing to use these tubes are instructed to uncap the tubes and analyze the samples,as open vial samples.
Quantity in commerce: 2709
Distribution: Nationwide and Canada
Product codes and lots: All codes

Product code GKZ

K990352Class IICoulter Ac T Diff 2 AnalyzerCoulter Corp. / cleared 1999-04-01

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)