PRA number
Published date
Product description
Accu-Chek Solo Cannula Assembly & Pump Holder (9 mm; 10+3 & 6 mm; 10+3) and Accu-Chek Solo Supply Kit (9 mm) & (6 mm)
Cannula lot numbers: 847468303 and lower
Reference numbers: 07858833001, 07858841001, 07858817001 & 07858825001
ARTG 308704
(Roche Diabetes Care Australia Pty Ltd - Insulin infusion patch pump administration set)
ARTG 311432
(Roche Diabetes Care Australia Pty Ltd - Ambulatory insulin infusion administration set/reservoir kit)
Reasons the product is recalled
Insulin leakage has occurred with the Accu-Chek Solo Cannula Assembly and Pump Holder.
If the insulin leakage is not immediately noticed when using the Accu-Chek Solo system this could potentially lead to an under-delivery of insulin.
The hazards to consumers
If insulin is under-delivered, this may lead to adverse health events including severe hyperglycaemia or the user may experience diabetic ketoacidosis (DKA) and may require hospitalisation or intervention from a medical professional.
What consumers should do
Consumers should check whether they have an affected product and if so stop using them. Consumers should contact Roche Diabetes Customer Care to make arrangements to receive a replacement.
For more details see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01541-1
For further information, please contact Roche Diabetes Customer Care by phone on 1800 251 516.
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.