| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01351-1 |
| Product Name/Description |
Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems)
Catalogue/SMN Numbers: 10699201 and 10699533
Kit Lots ending in:
065 - Expiry: 09 Nov 2016
066 - Expiry: 30 Jan 2017
067 - Expiry: 11 Mar 2017
068 - Expiry: 23 Apr 2017
069 - Expiry: 21 Jul 2017
070 - Expiry: 25 Aug 2017
ARTG Number: 175700 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed a change in correlation between serum and plasma specimen tubes with the ADVIA Centaur Vitamin D Total assay as compared to Instructions for Use (IFU). The bias observed between serum and plasma samples has the potential to impact interpretation of vitamin D status in the event the patient's vitamin D level is at or near the cut-offs for Deficient versus Insufficient or Insufficient versus Sufficient. This may lead to the initiation of unnecessary vitamin D supplementation and/or additional monitoring of vitamin D levels. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising customers that they may continue to use the ADVIA Centaur Vitamin D Total assay with both serum and plasma specimen types, however, they should consider the bias when evaluating samples in different tube types. Siemens will contact customers when the updated Instructions For Use (IFU) is available for download from Siemens Doc Library.
This action has been closed out on 13/11/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |