Open official notice

Accu-Chek Guide and Accu Chek Performa Blood Glucose Meters

Official notice

21 Nov 2019

RecallScope risk estimate:HighACCC

An official ACCC notice concerns Accu-Chek Guide and Accu Chek Performa Blood Glucose Meters. If users are unable to monitor blood glucose levels to determine the insulin dose or make treatment decisions, this may lead to incorrect dosing decisions, which can lead to serious health complications. Published 2019-11-21.

What to do now

Roche will contact affected customers in writing. Customers are advised to follow the instructions provided in the customer letter and the following warnings: 1. Always have a spare set of high quality batteries 2. Battery life may vary due to factors such as temperature and battery manufacturer 3. Have a back-up testing method available Further information can be obtained from the website at https://www.accu-chek.com.au/#alerts For further information, contact the Roche Diabetes Care Enquiry line on 1800 251 816

Recall number

09cde255-b599-4d69-82e4-754a65f5e2ad

Official notice

2019-11-21

The hazard

If users are unable to monitor blood glucose levels to determine the insulin dose or make treatment decisions, this may lead to incorrect dosing decisions, which can lead to serious health complications.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Check the official notice for the affected products and next steps.

Artg Numbers

190250, 273957

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Affected products

Product 1

Accu-Chek Guide Meter Serial Numbers below 92911000001 ARTG 190250 Accu-Chek Performa Meter Serial Numbers between 68920000000 and 68925525056 ARTG 190250 Accu-Chek Guide Meter Kit Serial Numbers below 92911000001 ARTG 273957 Accu-Chek blood glucose meters. An in vitro diagnostic medical device (IVD)

Hazard

If users are unable to monitor blood glucose levels to determine the insulin dose or make treatment decisions, this may lead to incorrect dosing decisions, which can lead to serious health complications.

Where it was sold

Retailer information is not currently available in RecallScope. Check the official notice for distribution details.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Official classification

Pharmacy and medical products

Recall details

Recall number

09cde255-b599-4d69-82e4-754a65f5e2ad

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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