Class Ill ABX Diagnostics

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.