FDA Device

PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

Hazard

Power failure having impact on software.

What You Should Do

Remedy

Firm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.

Products

PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
Brand
ABX Diagnostics Inc
UPC
Any instrument which is not equipped with v4.55 or above will be upgraded.

Units Affected

81