Z-0002-05

Automated Differential Cell Counter

Name: Z-0002-05 Automated Differential Cell Counter
Creator: ABX Diagnostics Inc
Published: 2004-08-13
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2004-08-13 / Terminated

FDA source

ABX Diagnostics Inc began a recall of Automated Differential Cell Counter on 2004-08-13. The reason FDA records is "Device can generate overestimated platelet results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0002-05
Status: Terminated
Initiated: 2004-08-13
Posted: 2004-10-05
Terminated: 2005-09-02
Recalling firm: Horiba Instruments Incorporated
Product: Automated Differential Cell Counter
Product code: GKZ Counter, Differential Cell
Reason for recall: Device can generate overestimated platelet results.
FDA root cause: Other
Action: Software problem, device may give overestimated platelet results.
Quantity in commerce: 91
Distribution: Nationwide
Product codes and lots: Part Numbers: Pentra 80 P8000000NUA10

Product code GKZ

K024002Class IIPentra 80Abx Diagnostics / cleared 2003-01-03

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)