Class Il Radiometer America Inc

Company:Radiometer America Inc.
Date of Enforcement Report:8/16/2006
Class:lI

PRODUCT
a) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer,
ABL-700 series, Recall # Z-1317-06;
b) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer,
ABL-800 series, Recall # Z-1318-06

REASON
Software defect. pO2 and pCO2 sample test results run on the firm’s ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase..

CODE
a) All analyzers manufactured from 1/1999-12/2005. The devices
contain serial numbers 902-441RxxxNxxx. The Rxxx number
denotes manufacturing run, and the Nxxx number denotes the
individual instrument within the run;
b) All analyzers manufactured from 1/2005-10/31/2005. The devices
contain serial numbers 902-441RxxxNxxx. The Rxxx number
denotes manufacturing run, and the Nxxx number denotes the
individual instrument within the run.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc, WestlakeOH, by letter on June 17, 2005
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
Series 700 — 1,635 Analyzers;
Series 800 — 108 Analyzers

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.