| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00546-1 |
| Product Name/Description |
Alegria Anti-Intrinsic Factor Assay
Product Code: ORG 247-24
Lot Numbers: 24732425, 24732427 & 24733840 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Analysis in Quality Control has identified and confirmed that the lots listed above of our Alegria test ORG 247, anti-Intrinsic Factor, exhibit an overall lower level of optical density values. This effect bears the risk that some positive sample-values will fall below the cut-off and will falsely be read as negative. |
| Recall Action |
Recall |
| Recall Action Instructions |
Immuno requested thier customers to destroy any remaining product from the affecetd lots. Due to the risk of false negative results Immuno recommended that negative samples where clinical symptoms of pernicious anaenia should be retested. This action has been closed-out on 18/02/2016. |
| Contact Information |
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