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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Corporate Office

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