Class 2 Device Recall OMNI 8

• Date Initiated by Firm: December 15, 2003
• Date Posted: January 10, 2004
• Recall Status: Terminated on August 02, 2004
• Recall Number: Z-0327-04
• Recall Event ID: 27922
• 510(K)Number: K972733
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R.
• Code Information: All units with software version 5.61 or below.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-526-2272
• Manufacturer Reason for Recall: If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.
• 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 and Original Applicant = AVL SCIENTIFIC CORP.