Z-1342-04

PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

Name: Z-1342-04 PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
Creator: ABX Diagnostics Inc
Published: 2004-06-24
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2004-06-24 / Terminated / root cause: software

FDA source

ABX Diagnostics Inc began a recall of PENTRA 120 and PENTRA 120 Retic Hematology Analyzer on 2004-06-24. The reason FDA records is "Power failure having impact on software". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1342-04
Status: Terminated
Initiated: 2004-06-24
Posted: 2004-08-13
Terminated: 2005-09-02
Recalling firm: Horiba Instruments Incorporated
Product: PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
Product code: GJH Stain, Reticulocyte
Reason for recall: Power failure having impact on software.
Root cause tag: software
FDA root cause: Other
Action: Firm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.
Quantity in commerce: 81
Distribution: Nationwide.
Product codes and lots: Any instrument which is not equipped with v4.55 or above will be upgraded.

Product code GJH

K022200Class IIPentra 120/Pentra 120 Retic Options Sps, Model Pentra 120Abx Diagnostics / cleared 2002-07-29

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)