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Terminated

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

FDA Recall Z-1334-06 · Posted 2006-08-03

Recalling FirmABX Diagnostics Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2006-03-24
Date Terminated2012-05-23

Reason for Recall

Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050719ABX PENTRA DX 120: OPTION SPS EVOLUTIONHoriba Abx · 2005-04-26K022200PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120Abx Diagnostics · 2002-07-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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