Blood Glucose Meter Recall: Accu-Chek Guide May Display Incorrect Measurement Units
Roche is recalling Accu-Chek Guide (SC) blood glucose meters that may display readings in mmol/L instead of mg/dL, appearing approximately 18 times lower than actual. This could lead to incorrect treatment decisions and long-term diabetes complications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with serious potential consequences including unrecognized hyperglycemia and long-term diabetes complications (microvascular and macrovascular events). No illnesses or injuries have been reported; the defect was identified through consumer complaints regarding unit display errors.
Plain-English summary
The Accu-Chek Guide (SC) Kit is a blood glucose meter manufactured by Roche Diabetes Care, Inc. that measures glucose levels in fresh capillary whole blood from the fingertip, palm, and upper arm. Roche is recalling these devices due to a defect that may cause meters to display glucose readings in mmol/L (millimoles per liter) instead of the intended mg/dL (milligrams per deciliter).
When meters display the wrong unit of measure, the numeric value appears approximately 18 times lower than the actual blood glucose level. A patient who interprets this as low blood sugar (hypoglycemia) may receive inappropriate rescue treatment with carbohydrates, potentially causing repeated episodes of unrecognized and undertreated high blood sugar (hyperglycemia).
Continued use of affected meters could result in prolonged mismanagement of diabetes. Over extended periods, unrecognized and undertreated hyperglycemia may contribute to serious long-term complications including microvascular complications (retinopathy, neuropathy, nephropathy) and macrovascular complications (heart attack, stroke). In pregnant women, prolonged hyperglycemia could contribute to fetal damage, including abnormal fetal growth and organ development, fetal low oxygen levels, miscarriage, and birth defects.
The recall affects Accu-Chek Guide (SC) Kit (Product REF Number: 08453071001) distributed nationwide and worldwide. The defect was identified following three consumer complaints regarding incorrect unit display. Affected serial numbers are specified for U.S. and Canadian distribution.
The recalled product
- 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
- Manufacturer
- Roche Diabetes Care, Inc.
- Hazard
- incorrect-measurement-unit
- hyperglycemia
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- GTIN: 00365702729100 Serial Numbers: US: 92339920445
- 92340117408
- 92339920116
- 92339955415
- 92340120006
- 92339094787
- 92340116052
- 92340120057
- 92339744998. Canada:93040305146
Distribution
Distributed nationwide across the United States.
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