Inc, Class IIl Radiometer America

Company: Radiometer America, Inc,
Date of Enforcement Report:8/16/2006
Class:lIl

PRODUCT
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21, Recall # Z-1325-06

REASON
ABL800 Series Blood Gas Analyzer became inoperable when the restore default setup button was touched..

CODE
Software Versions 5.21 i.e. ABL8xx 754R00xx N0xx

RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by memo and visits beginning on October 31, 2005.
Manufacturer: Radiometer Medical Aps, Bronshoj, Denmark. Firm initiated recall is complete

VOLUME OF PRODUCT IN COMMERCE
36 analyzers

DISTRIBUTION
Nationwide and Internationally

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.