Class 2 Device Recall Roche/Hitachi Modular E Module

• Date Initiated by Firm: June 24, 2008
• Date Posted: October 22, 2008
• Recall Status: Terminated on October 22, 2009
• Recall Number: Z-0165-2009
• Recall Event ID: 48711
• 510(K)Number: K961481
• Product Classification: Chemistry Analyzer - Product Code JJE
• Product: Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
• Code Information: All units with software version 08-02.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-428-2336
• Manufacturer Reason for Recall: A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
• FDA Determined Cause: Other
• Action: The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.
• Distribution: Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.
• 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