RecallDepth

Automated Differential Cell Counter

This recall has been terminated (originally issued October 5, 2004).

Company
Abx Diagnostics Inc
Recall Initiated
August 13, 2004
Posted
October 5, 2004
Terminated
September 2, 2005
Recall Number
Z-0002-05
Quantity
91
Firm Location
Irvine, CA
Official Source
View on FDA website ↗

Reason for Recall

Device can generate overestimated platelet results.

Distribution

Nationwide

Lot / Code Info

Part Numbers: Pentra 80 P8000000NUA10

Root Cause

Other

Action Taken

Software problem, device may give overestimated platelet results.

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