| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00225-1 |
| Product Name/Description |
i-STAT1 Analyser when used with i-STAT Celite Activated Clotting Time (ACT) & Kaolin ACT Cartridges. An in vitro diagnostic medical device (IVD).
i-STAT1 Analyser – software version JAMS142E
i-STAT Celite ACT Cartridges
List Number: 03P86-25
i-STAT Kaolin ACT Cartridges
List Number: 03P87-25
ARTG Numbers: 203350, 213851 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
15/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Point of Care Inc. has determined that Celite ACT and Kaolin ACT cartridges may produce falsely low results when very high clotting time samples are tested when using i-STAT1 Analyser Software version JAMS142E. Patient samples with a measured clot time of >853 seconds for Celite and >1134 seconds for Kaolin may display results of approximately 100 to 200 seconds. The typical therapeutic range of the i-STAT ACT assay is 200 to 600 seconds and results in this range are not affected by this issue. Only individual patient results where the measured clot time is >853 seconds for Celite ACT and >1134 seconds for Kaolin ACT are impacted. The i-STAT System provides the user with an ongoing estimate of the clot time as the ACT cartridges are running, referred to as the count up bar. The count up bar is not impacted by this issue. The ongoing estimates that the user receives during the cartridge run are correct. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To correct the issue, Abbott is advising customers to update all i-STAT analysers performing Celite ACT or Kaolin ACT testing with software version JAMS142G, which is available from the Abbott Point of Care website. A look back of results is not required, as results obtained within the typical therapeutic range of 200 to 600 seconds are not affected, only individual patient results where the measured clot time is >853 seconds for Celite ACT and >1134 seconds for Kaolin ACT are impacted and monitoring of the activated clotting time is happening in real time during a procedure. This action has been closed-out on 04/07/2017. |
| Contact Information |
1800 616 696 - Abbott Point of Care Technical Support |