Class 2 Device Recall

• Date Initiated by Firm: August 06, 2004
• Date Posted: September 02, 2004
• Recall Status: Terminated on June 26, 2006
• Recall Number: Z-1428-04
• Recall Event ID: 29648
• 510(K)Number: K901003
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
• Code Information: All units.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Technical Support; 800-428-2336
• Manufacturer Reason for Recall: A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.
• FDA Determined Cause: Other
• Action: Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.
• Quantity in Commerce: 254
• 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