| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01541-1 |
| Product Name/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) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2022 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diabetes Care has identified that insulin leakage has occurred in a low number of cases with the Accu-Chek Solo cannula assembly & pump holder. As such insulin leakage might not be noticed immediately when using the Accu-Chek Solo system which could potentially lead to an under-delivery of insulin.
The possible consequences could range from no clinical impact to adverse health events including severe hyperglycaemia or diabetic ketoacidosis (DKA).
There have no reports of adverse events been reported in Australia to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche are advising consumers, healthcare professionals and distributors to identify impacted products and discontinue using them. Customers are also advised to contact Roche customer care to receive the information on how to send the impacted stock back and receive the replacement.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 251 516 - Diabetes customer care - Roche |