RecallDepth

Pentra 80 and Pentra 80XL Hematology Analyzers

This recall has been terminated (originally issued December 23, 2005).

Company
Abx Diagnostics Inc
Recall Initiated
April 8, 2004
Posted
December 23, 2005
Terminated
February 6, 2006
Recall Number
Z-0298-06
Quantity
67
Firm Location
Irvine, CA
Official Source
View on FDA website ↗

Reason for Recall

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

Distribution

Nationwide.

Lot / Code Info

All Serial numbers.

Root Cause

Other

Action Taken

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

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