| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00710-1 |
| Product Name/Description |
ABL800 Basic and ABL8XX FLEX. An in vitro diagnostic medical device (IVD)
All ABL800 Basic and ABL8XX FLEX analysers with software versions below V6.19 MR2
Item numbers 393-805, 393-806, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844
ARTG 228382
(Radiometer Pacific Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/05/2022 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has become aware of a potential issue with ABL800 Basic and ABL8XX FLEX analysers with software versions below V6.19 MR2 and configured to report cNa+.
Radiometer have received reports of sporadic incidents of positive and negative biases for cNa+, that potentially could lead to serious health consequences, including body function impairment and put the patient at risk for developing severe hyponatremia or hypernatremia.
The issue may show when using the following specific micro measuring modes:
· Capillary - C95 µL,
· Capillary – FLEXMODE,
· Syringe - S95 µL,
· Capillary - C125 µL
Other measuring modes and parameters are not affected. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised that a Radiometer representative will be in contact to schedule a visit, or a remote session, to upgrade their analysers software version to 6.19 MR2 or higher, expected completion in 9-12 months.
In the interim, customers should not use results for cNa+ for any of the affected micro measuring modes. To remove/deselect the cNa+ parameter results from the affected modes, customers should follow the instructions provided in the customer letter by the sponsor.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 247 254 - Radiometer Pacific Pty Ltd |