| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00915-1 |
| Product Name/Description |
Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD).
IMMULITE/IMMULITE 1000 FT3
Catalog Number: LKF31
Siemens Material Number: 10381626
Lot Numbers: 353 & 354
IMMULITE 2000/IMMULITE 2000 XPi FT3
Catalog Numbers: L2KF32 & L2KF36
Siemens Material Numbers: 10381675 & 10381682
Lot Numbers: 737, 738, 739, 740, 741, 742 & 743
ARTG number: 179720
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
The IMMULITE/ IMMULITE 1000/ IMMULITE 2000 and IMMULITE 2000 XPi Free T3 Assay kit lots listed with adjustor (LF3L/H) Lot #135 are showing an elevated shift in patient values that exceed the upper limits of the normal reference range referenced in the IMMULITE Free T3 Instructions For Use (IFU). The elevated IMMULITE Free T3 results will not correlate with the results of other thyroid markers or Free T3 results generated on other platforms. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting their customers to cease using the affected lots of reagent. Replacement with unaffected lots can be arranged to replace any stock. A look back of previously reported results is not recommended by Siemens as the assessment of thyroid function is generally based on multiple markers. However, the requirement for a look back should be determined at the discretion of the laboratory. Thia action has been closed-out on 29/01/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |