Class 2 Device Recall

• Date Initiated by Firm: December 29, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on February 20, 2004
• Recall Number: Z-0336-04
• Recall Event ID: 27989
• 510(K)Number: K945915 K954018 K972733 K990092
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
• Code Information: All units.
• FEI Number: 1823260
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-526-2272
• Manufacturer Reason for Recall: The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
• FDA Determined Cause: Other
• Action: A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.
• Distribution: United States.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = JJE