| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00164-1 |
| Product Name/Description |
ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD)
List Number: 8K25
Reagent List Numbers: 8K25-20, 8K25-25
Calibrator List Numbers: 8K25-01
Control List Numbers: 8K25-10
Multiple Lot Numbers affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has confirmed that a performance shift in the ARCHITECT Intact Parathyroid (PTH) assay has the potential to generate falsely elevated results on patient samples.
Results generated with impacted lots may demonstrate a positive shift averaging approximately 13% to 45% relative to those generated with previous reagent and/or calibrator lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott is advising users to immediately discontinue use and discard affected stock and to identify an alternative method of testing patient samples.
Abbott is recommending the letter is reviewed with the treating physician to determine if re-evaluation of the patient is required. This action has been closed-out on 02/02/2016. |
| Contact Information |
1800 816 696 - Abbott Customer Support |