Company:ABX Diagnostics
Date of Enforcement Report:8/23/2006
Class:lll
PRODUCT
ABX Pentra 120, 120R, 120DX, automated hematology analyzer, Recall # Z-1334-06
REASON
Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample..
CODE
All serial numbers, all software versions.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ABX Diagnostics, Inc., Irvine, CA, by letter and telephone on March 24, 2006.
Manufacturer: Horiba ABX, Montpellier, France. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
86 units
DISTRIBUTION
Nationwide
