| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00227-1 |
| Product Name/Description |
Alere Cholestech LDX Multianalyte Control (An in vitro diagnostic medical device used to monitor the performance of total cholesterol (TC), high density lipoprotein (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System)
Catalogue Number: CT88769
Lot Numbers: C2572, C2572A, C2593 & C2593A
ARTG Number: 160951 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Investigations of the affected lot numbers have indicated that these lots of controls may yield results which are out of range high when tested with the Alere Cholestech LDX HDL test. |
| Recall Action |
Recall |
| Recall Action Instructions |
Inverness Medical Innovations (trading as Alere) is asking customers to discontinue the use of the affected lots and destroy all remaining stock. Customers have been advised that If the controls have been within the ranges shown on the value assignment card that came with the control materials, then the patient results should be considered clinically acceptable. Replacement product is expected to be available in approximately 4 – 6 weeks. |
| Contact Information |
07 3363 7711 - Alere Technical Support |