Class 2 Device Recall Roche Diabetes Care, Inc., AccuChek Guide Meter

• Date Initiated by Firm: May 13, 2024
• Date Posted: June 21, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2174-2024
• Recall Event ID: 94655
• 510(K)Number: K160944
• Product Classification: System, test, blood glucose, over the counter - Product Code NBW
• Product: Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001
• Code Information: GTIN: 00365702729100 Serial Numbers: US: 92339920445, 92340117408, 92339920116, 92339955415, 92340120006, 92339094787, 92340116052,92340120057, 92339744998. Canada:93040305146
• Recalling Firm/ Manufacturer: Roche Diabetes Care, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Amy Lynnr ; 317-521-0251
• Manufacturer Reason for Recall: The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.
• FDA Determined Cause: Reprocessing Controls
• Action: Roche issued Urgent Medical Device Removal letter on 5/13/24 to US distributors, direct accounts, & end users. Letter states reason for recall, health risk and action to take: We ask all users of the Accu-Chek Guide blood glucose monitoring system to " Please check your meter to see if the display shows the appropriate measuring unit (mg/dL) " Please compare the serial number of your meter with the listed affected serial numbers to determine if it is impacted by this issue. Please see the affected serial numbers below. 92339920445 92340117408 92339920116 92339955415 92340120006 92339094787 92340116052 92340120057 92339744998 " Please stop using your Accu-Chek Guide meter if you notice that your product shows an incorrect measuring unit or the serial number is one of the listed impacted products and: " Please visit http://accu-chek.com/notices/UMDR-24-001 and enter your serial number. The form will provide instruction on how to proceed. Otherwise, you may contact our Roche Diabetes Care Accu-Chek Customer Care line at 1-800-858-8072 (Monday Friday from 8:00 a.m. ET - 8:00 p.m. ET). " Please keep this UMDR for future reference. UPDATE: The Canadian affiliate was informed of the issue with this serial number via video conference on 21 May 2024. The updated appendix was provided to the Canadian affiliate on 27 May 2024.
• Quantity in Commerce: 48 units
• Distribution: Nationwide and Worldwide
• 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 = NBW