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Terminated

Pentra 80 and Pentra 80XL Hematology Analyzers

FDA Recall Z-0298-06 · Posted 2005-12-23

Recalling FirmABX Diagnostics Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2004-04-08
Date Terminated2006-02-06
Product Quantity67

Reason for Recall

Software defect, instrument may erroneously give a result of '0' or '---'.

Firm Action

Firm sent a notification/recall letter on April 8, 2004. They plan to modify the software in August 2004.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

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

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