RecallDepth

ABX Diagnostices Pentra 60C+ Hematology Analyzer

This recall has been terminated (originally issued August 21, 2003).

Company
Abx Diagnostics Inc
Recall Initiated
June 4, 2003
Posted
August 21, 2003
Terminated
June 17, 2014
Recall Number
Z-1149-03
Quantity
159
Firm Location
Irvine, CA
Official Source
View on FDA website ↗

Reason for Recall

Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.

Distribution

Nationwide.

Lot / Code Info

Software versions of up to 1.7

Root Cause

Other

Action Taken

The firm distributed a 'Product Advisory Note' on June 5, 2003 by mail which includes instructions on how to avoid problems. It also mentions a new software release which will fix the problem.

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