| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00652-1 |
| Product Name/Description |
ADVIA Centaur CA 19-9. An in vitro diagnostic medical device (IVD).
ADVIA Centaur CA 19-9 (50 Test)
UDI: 10491379 / 00630414574257
Kit Lot Numbers: 55970535, 55971535
ADVIA Centaur CA 19-9 (250 Test)
UDI: 10491244 / 00630414574028
Kit Lot Numbers: 55972535, 55973535
Test Code: CA-19-9
Expiry Date: 14/09/2024
ARTG 175636
(Siemens Healthcare Pty Ltd- Clinical chemistry tumour marker IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
1/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is a positive bias in some samples around a concentration of 37 U/mL with lots 55970535, 55971535, 55972535, 55973535 when compared to the previous lot. A sample bias was observed in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to discontinue use of and discard the affected kit lots appropriately. Replacement product can be requested from customers' local Siemens Healthineers or distributor office at no charge. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |