Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18129 |
| Brand Name: | Siemens Immulite GI-MA CA19-9 |
| Model: | Catalogue Number: L2KGI2 |
| Affected: | Lots: 312, 313. Expiry date: 2015-12-31 |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Products Limited |
| Issue: | Siemens Healthcare Diagnostics has confirmed a positive bias with the Bio-Rad Lyphochek® Tumor Marker Plus Control and the Bio-Rad Liquichek™ Tumor Marker Control when used with IMMULITE® 2000/IMMULITE® 2000 XPi GI-MA (CA 19-9) assay kit lots 312 and 313. In addition, a greater than expected change in patient sample recovery may be observed when moving from kit lot 311 to kit lots 312 and above. 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 type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/2/2015 |
