Class 2 Device Recall AccuChek

• Date Initiated by Firm: February 12, 2003
• Date Posted: April 09, 2003
• Recall Status: Terminated on September 15, 2003
• Recall Number: Z-0716-03
• Recall Event ID: 25542
• 510(K)Number: K982089
• Product Classification: Glucose Dehydrogenase, Glucose - Product Code LFR
• Product: Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Road; Indianapolis IN 46250-0457
• For Additional Information Contact: 800-858-8072
• Manufacturer Reason for Recall: Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
• FDA Determined Cause: Other
• Action: Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.
• Distribution: United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Norway, Pakistan, Peru, Philippines, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom and Vietnam.
• 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 = LFR and Original Applicant = BOEHRINGER MANNHEIM CORP.