FDA Device

Pentra 80 and Pentra 80XL Hematology Analyzers

Hazard

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

What You Should Do

Remedy

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

Products

Pentra 80 and Pentra 80XL Hematology Analyzers
Brand
ABX Diagnostics Inc
UPC
All Serial numbers.

Units Affected

67