Z-1149-03

ABX Diagnostices Pentra 60C+ Hematology Analyzer

Name: Z-1149-03 ABX Diagnostices Pentra 60C+ Hematology Analyzer
Creator: ABX Diagnostics Inc
Published: 2003-06-04
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2003-06-04 / Terminated

FDA source

ABX Diagnostics Inc began a recall of ABX Diagnostices Pentra 60C+ Hematology Analyzer on 2003-06-04. The reason FDA records is "Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1149-03
Status: Terminated
Initiated: 2003-06-04
Posted: 2003-08-21
Terminated: 2014-06-17
Recalling firm: Horiba Instruments Incorporated
Product: ABX Diagnostices Pentra 60C+ Hematology Analyzer
Product code: GKZ Counter, Differential Cell
Reason for recall: Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
FDA root cause: Other
Action: The firm distributed a 'Product Advisory Note' on June 5, 2003 by mail which includes instructions on how to avoid problems. It also mentions a new software release which will fix the problem.
Quantity in commerce: 159
Distribution: Nationwide.
Product codes and lots: Software versions of up to 1.7

Product code GKZ

K003677Class IIAbx Pentra 60C+ Hematology AnalyzerAbx Diagnostics / cleared 2000-12-26

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)