| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00350-1 |
| Product Name/Description |
IMMULITE 2000 and IMMULITE 2000 XPi Anti-TG Ab. An in vitro diagnostic medical device (IVD)
Catalogue #: L2KTG2/10381659/ 00630414962108
Lot #: 782, 783, 786, 787, 788, 789, 791, 792, 793
ARTG 179722
(Siemens Healthcare Pty Ltd - Clinical chemistry autoimmune IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
Potential for falsely elevated patient sample results when using impacted kit lots of IMMULITE 2000 and IMMULITE 2000 XPi Anti-TG Ab. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should:
· Review the customer letter with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
· Discontinue use of and discard the kit lots affected.
· May request no-charge replacement product from your local Siemens Healthineers or distributor office. New unaffected lots have been released. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre or 0488 700 976 Sue Sterling |