| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00778-3 |
| Product Name/Description |
ARCHITECT Toxo IgG; An in vitro diagnostic medical device (IVD)
List Number: 6C19-25
Lot Numbers: 15070LI00 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
ARCHITECT Toxo IgG reagent lots 15070LI00 (List number 6C19-25) are showing reduced specificity which may cause a shift to higher IU/mL values leading to increased grayzone and/or reactive results. The assay sensitivity is not impacted and current data indicated that no other lots are affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and discard affected products. Abbott recommends discussing previous results with Laboratory Management and healthcare providers to determine if any further testing is required. |
| Contact Information |
1800 816 696 - Abbott Customer Support |