| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01411-1 |
| Product Name/Description |
i-STAT 1 Analyser Software with i-STAT Total â-hCG Cartridge with software version JAMS 143/CLEW A34. An in vitro diagnostic medical device (IVD)
ARTG Number: 203349
(Abbott Australasia Pty Ltd (Point-of-Care Division) - Clinical chemistry hormone IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
13/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Through a combination of internal studies and customer reports, Abbott Point of Care has determined that users may experience an increased frequency of Quality Check Code 149 when testing i-STAT Total ß-hCG cartridges with i-STAT 1 Analyser software version JAMS 143 / CLEW A34.
There is no impact on user/patient safety. Due to the fact that Quality Check Code 149 requires the test to be repeated, this issue has the potential to delay generation of i-STAT Total ß-hCG results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott is advising facilities performing testing with i-STAT Total ß-hCG cartridges, to verify that all i-STAT analysers performing i-STAT Total ß-hCG testing have been updated to software version JAMS 144 / CLEW A35. If the software has not yet been updated to version JAMS 144 / CLEW A35, please follow the directions on the Abbott Point of Care website (see link below) for the installation of the software.
https://www.pointofcare.abbott/us/en/offerings/support/software-license-keys/istat-system-software-update .
This action has been closed out on 31/05/2019 |
| Contact Information |
1800 816 696 - Abbott Point of Care Technical Support |