| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00561-1 |
| Product Name/Description |
ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. An in vitro diagnostic medical device (IVD)
100 Test Kit
List Numbers: 3P25-25, 3P25-26
Multiple Lot Numbers affected
500 Test Kit
List Numbers: 3P25-35, 3P25-36
Multiple Lot Numbers affected
ARTG Number: 208227 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Predictive quality assurance monitoring of ARCHITECT STAT High Sensitive Troponin-I reagent lots was initiated following a field action on a single lot of ARCHITECT STAT High Sensitive Troponin-I reagent in January, which impacted only selected countries. As a result, Abbott has identified a potential for increased calibration failures prior to the expiration date.
There is no impact to generated patient results. There is a potential for delay in results due to calibration errors and failure to calibrate which may lead to delayed treatment of life threatening injury. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott is advising users that for certain lots, affected products can be used provided the calibration passes. Alternative lots should be ordered as soon as possible, and if the calibration fails to use an alternative lot. Once an unaffected lot is available, any remaining affected lots should be discarded.
For certain lots, the expiration date should be amended as instructed. The expiration date for these lots will need to be manually tracked, as the system will maintain the original expiry date.
Abbott is advising users that all new stock will have the expiry dates lowered to 4 months until corrective actions can be implemented.
This action has been closed-out on 28/02/2018. |
| Contact Information |
1800 816 696 - Abbott Customer Support |