| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00036-1 |
| Product Name/Description |
Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD)
Test Code: OCN
Catalogue Number: L2KON2
Lot Numbers: 218, 219, 220 & 221
Siemens Material Number: 10381477
ARTG Number: 179720 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed under recovery up to 50% in patient values across the assays reportable range with the affected IMMULITE 2000/IMMULITE 2000 XPi Osteocalcin (L2KON2) kit lots. Quality Control materials will not detect the bias.
Osteocalcin can serve as a measure of increased bone resorption in some patient. Depending upon the treatment approach, the measurement of osteocalcin may correlate to therapy. In some patients risk of osteoporosis correlates of increasing values of osteoclacin. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens Healthcare is advising users to discontinue and discard affected lots. Siemens does not currently have a replacement for this product. Siemens is recommending discussing this notice with the medical director regarding the need to review previous test results, conduct patient follow and / or repeat testing for patients tested with the affected lots. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |