Class 2 Device Recall AccuData

• Date Initiated by Firm: April 18, 2005
• Date Posted: June 11, 2005
• Recall Status: Terminated on March 07, 2006
• Recall Number: Z-0882-05
• Recall Event ID: 31619
• 510(K)Number: K924475
• Product Classification: Glucose Oxidase, Glucose - Product Code CGA
• Product: Roche brand AccuData GTS System; Catalog number 404, material number 03136833001.
• Code Information: All units.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Customer service; 800-440-3638
• Manufacturer Reason for Recall: If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.
• Distribution: Nationwide and Guam.
• 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 = CGA and Original Applicant = BOEHRINGER MANNHEIM CORP.