| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01250-1 |
| Product Name/Description |
ARCHITECT Active-B12 (Holotranscobalamin). An in vitro diagnostic medical device (IVD)
List Numbers: 3P24-25 / 3P24-35
Lot Numbers: 10112UP00, 10113UP00 and 1013UP00 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has confirmed that the ARCHITECT Active-B12 assay is not meeting the Method Comparison slope claim of 1.0 +/- 0.1 as stated in the Package Insert (commodity number ABBL331/R02). A positive bias of approximately 20-30% has been observed when compared to a commercially available diagnostic kit.
This recall action was not notified to the TGA before it was initiated by Abbott. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott is providing work around instructions for users to follow and is advising users that once they receive the next reagent lot after the affected lots to re-establish the laboratory's reference ranges prior to evaluating future patient results. |
| Contact Information |
1800 816 696 - Abbott Customer Support |