| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00131-1 |
| Product Name/Description |
IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Bias. An in vitro diagnostic medical device (IVD)
Catalogue Number: L2KGI2
Siemens Material Number: 10380988
Lot Numbers: 312 and 313
ARTG Number: 180780 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed a positive bias with the Bio-Rad Lyphochek Tumor Marker Plus Control and the Bio-Rad Liquichek Tumour Marker Control when used with IMMULITE 2000/IMMULITE 2000 XPi GI-MA (CA 19-9) assay kit lots 312 and 313.
The bias in quality control values is the result of the introduction of a new lot of the bead coat antibody (murine monoclonal anti-CA 19-9 antibody) in kit lot 312.
When comparing kit lot 312 with kit lot 311, Siemens observed an average percent bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 U/mL and an average percent bias of 5% (ranging from 1% to 11%) for patient samples recovering from 540 to 660 U/mL.
Future kit lots are expected to recover quality control and patient samples similar to kit lot 312. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising that patients may need to be re-base lined with kit lot 312 or higher. A look back over previously generated results should be discussed with the treating physician.
This action has been closed out on the 17/10/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |