Accu-Chek Guide
Brand(s)
Last updated
Summary
Product
Accu-Chek Guide
Issue
Medical devices - Labelling and packaging
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Accu-Chek Guide | Lot 406670 Lot 406711 SN 93040301566 SN 93040300107 SN 93040304746 SN 93040305146 | 07398832004 |
Issue
The issue arises when a blood glucose measurement is taken and the result is displayed in the wrong measuring unit (i.e., mg/dl instead of mmol/l). If it goes unnoticed, the incorrectly displayed blood glucose value may result in inappropriate therapy decisions, including the administration of insulin, and could potentially result in severe consequences. Such possible consequences range from no clinical impact to adverse health events such as hypoglycemia.
Recall start date: May 14, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
| Roche Diabetes Care Gmbh |
| Sandhofer Strasse 116, Mannheim, Germany, 68305 |
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-75885
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