| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00226-1 |
| Product Name/Description |
Alere Cholestech LDX hsCRP Cassette (An in vitro medical device (IVD) used in the quantitative determination of C-reactive protein in whole blood or serum )
Catalogue Number: CT12-807
Lot Numbers: 274632 & 281847/14
ARTG Number: 160951 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2013 |
| 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 hsCRP 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 hsCRP 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 hsCRP cassette has been suspended, effective immediately, and no additional product will be available. |
| Contact Information |
07 3363 7711 - Alere Technical Support |