Public recall detail

Accu-Chek Guide

2024-07-31

medium
Recall Safety notice
Quick summary

Quick summary: Accu-Chek Guide. Date: 2024-07-31.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Accu-Chek Guide. Date: 2024-07-31.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandRoche Diabetes Care Gmbh
ProductAccu-Chek Guide
IssueMedical devices - Labelling and packaging Medical devices - Performance
Recall classType II
IdentificationRA-75885

Affected products

ProductAccu-Chek Guide
LotLot 406670 Lot 406711 SN 93040301566 SN 93040300107 SN 93040304746 SN 93040305146
Model07398832004
Serial numberLot 406670 Lot 406711 SN 93040301566 SN 93040300107 SN 93040304746 SN 93040305146
DescriptionAccu-Chek Guide

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesRoche Diabetes Care Gmbh Sandhofer Strasse 116, Mannheim, Germany, 68305
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75885
Background{}
CompaniesRoche Diabetes Care Gmbh Sandhofer Strasse 116, Mannheim, Germany, 68305
AudiencesGeneral public Healthcare Industry
Source updated2024-09-26

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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