Z-1334-06

ABX Pentra 120,120R,120DX, automated hematology analyzer

Name: Z-1334-06 ABX Pentra 120,120R,120DX, automated hematology analyzer
Creator: ABX Diagnostics Inc
Published: 2006-03-24
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2006-03-24 / Terminated / root cause: labeling and UDI

FDA source

ABX Diagnostics Inc began a recall of ABX Pentra 120,120R,120DX, automated hematology analyzer on 2006-03-24. The reason FDA records is "Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1334-06
Status: Terminated
Initiated: 2006-03-24
Posted: 2006-08-03
Terminated: 2012-05-23
Recalling firm: Horiba Instruments Incorporated
Product: ABX Pentra 120,120R,120DX, automated hematology analyzer
Product code: GKZ Counter, Differential Cell
Reason for recall: Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Notifications have been prepared advising that following an occurrence observed outside of the United States, HORIBAABX is providing information regarding the rare circumstance of a label being incorrectly placed on a sample tube, resulting in a possible error in results attributed to a sample. The March 24, 2006, letter identifies various conditions in which the anomaly occurs. In order to prevent this type of incident, the firm recommends that the customer ensure that the identification label is firmly attached to the sample tubes during their positioning or removal from the racks.
Distribution: Nationwide
Product codes and lots: All serial numbers, all software versions.

Product code GKZ

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)