Class 2 Device Recall AccuChek Performa Test Strip

• Date Initiated by Firm: July 28, 2021
• Create Date: August 26, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2352-2021
• Recall Event ID: 88362
• 510(K)Number: K133741
• Product Classification: Glucose dehydrogenase, glucose - Product Code LFR
• Product: Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
• Code Information: Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
• Recalling Firm/ Manufacturer: Roche Diabetes Care, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Accu-Chek Customer Care; 1800-858-8072
• Manufacturer Reason for Recall: Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
• FDA Determined Cause: Package design/selection
• Action: On July 28, 2021, the firm issued an Urgent Medical Device Correction to affected customers regarding the potential for open vials. Customers were warned that open vials may expose the test strips to humidity, which might damage the strips and result in inaccurate results (such as positively biased or falsely too high results). Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences. ACTIONS REQUIRED BY USERS: 1. Check vials of affected test strips before use. DO NOT use test strips if: - The vial is open or damaged before using the test strips for the first time - The cap is not fully closed - You see any damage to the cap or vial, or - Anything prevents the cap from closing properly 2. DO NOT perform control testing if you open a sealed carton and ay of the vials inside meet the criteria listed above. 3. Contact Accu-Chek Customer Care for product replacement if you open a sealed carton and any of the vials inside meet the criteria listed above by phone at 1-800-858-8072 or on our website at Accu-Chek.com under Contact Us for email or chat. Please have the affected products available. 4. Complete and return the business reply letter to the recalling firm. 5. Dispose of the affected test strips and vial according to your local guidelines. Contact Accu-Chek Customer Care if you have questions regarding the information in this Urgent Medical Device Correction(UMDC) by phone at 1-800-858-8072 or on our website at Accu-Chek.com under Contact Us for email or chat.
• Quantity in Commerce: 146,854 (US); 59,815,555 (OUS)
• Distribution: Worldwide distribution - US Nationwide distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LFR