| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00437-1 |
| Product Name/Description |
ARCHITECT STAT High Sensitive Troponin-I Calibrators and Controls
ARCHITECT STAT High Sensitive Troponin-I Calibrators, LN 3P25-01
Lot number: 24057UI000
Expiry 9 July 2013
ARCHITECT STAT High Sensitive Troponin-I Controls, LN 3P25-10
Lot number: 24058UI00, Expiry 8 July 2013
Lot number: 26218UI00, Expiry 11 November 2013
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Although the calibrator and control products are currently performing as expected, during internal studies it was noted that ARCHITECT STAT High Sensitive Troponin-I calibrators and controls may decline in performance prior to their defined expiration dates. These kits were supplied for premarket evaluation of the kit. No patient results were reported from these reagent kits.
This recall action was not notified to the TGA before it was initiated by Abbott Australasia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott is requesting users to discontinue use and destroy calibrator lot 24057UI00 and control lot 24058UI00. Control lot 26218UI00 can continue to be used, however the expiry date for these units must be changed to 21 July 2013. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 816 696 - Abbott Customer Support |