| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00355-1 |
| Product Name/Description |
Alere Afinion ACR Control. An in vitro diagnostic medical device (IVD)
Catalogue Number: Af1116046
Lot Numbers: 10193874, 10195060
ARTG Number: 204476
(Inverness Medical Innovations Australia T/A Alere - Clinical chemistry substrate IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Alere has identified that the target values and acceptable ranges of albumin stated in the package insert of certain control lots is incorrect. The affected Alere Afinion ACR Control lots may give albumin results outside the acceptable range stated in the package insert.
The creatinine target values and acceptable ranges are not affected. The Alere Afinion ACR test kit is not affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Alere is advising customers to inspect stock for lots 10193874 and 10195060, discontinue use of, and discard all kits from the impacted lots. Alere will be providing replacement product to users.
This action has been closed out on the 15/11/2018. |
| Contact Information |
1800 622 642 - Alere Technical Support |