| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00624-1 |
| Product Name/Description |
RIA Coat-A-Count Androstenedione
Catalogue Number: TKAN1
Siemens Material Number: 10381049
Lot Numbers: 587 and above
ARTG Number: 210100 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has received complaints regarding the Coat-A-Count Direct Androstenedione assay demonstrating a higher frequency of results >10 ng/mL (>25 nmol/L) compared to alternate platforms. Through internal investigation Siemens has determined that there is a potential of cross-reactivity in circulating physiological serum levels up to 8.82% detected with spironolactone and its two metabolites, canrenone and 7a-thiomethyl spironolactone with the RIA CAC Direct Androstenedione assay. The degree of cross-reactivity is dependent on the circulating dose in the patients’ serum. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising pathology laboratories that the assay should not be used on patients being treated with spironolactone due to cross reactivity. These patients should be tested using an alternative method. A look back using another test method may be required if a patient has been administered spironolactone. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |