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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 Siemens Ltd Diagnostics Division
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