| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00225-1 |
| Product Name/Description |
Alere Cholestech LDX ALT-AST Cassette (An in vitro medical device (IVD) used for the quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in whole blood)
Catalogue Number: CT12-788
Lot Number: 297313A
ARTG Number: 160951 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
The product may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for ALT or AST compared to a reference method or repeat testing on the same patient sample. Such differences may not be detected by the Quality Control testing. |
| 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. If questions arise regarding any previously reported ALT or AST results, Alere is recommending customers to consult the resident clinical expert or physician in the setting where the test was performed. The manufacturing of the Alere Cholestech LDX ALT.AST cassette has been suspended indefinitely and no current estimate for when the product may return to the market |
| Contact Information |
07 3363 7711 - Alere Technical Support |