Recall Z-2174-2024 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diabetes Care, Inc.
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
| Date | Jun 21, 2024 (initiated May 13, 2024) |
| Status | Open, Classified |
| Reason | 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 unr |
| Root 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 92 |
| Quantity | 48 units |
| Distribution | Nationwide and Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System Roche Diabetes Care, Inc., Aug 31, 2016 |