| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00357-1 |
| Product Name/Description |
Dimension Vista Systems LOCI Thyroid Stimulating Hormone. An in vitro diagnostic medical device (IVD)
Assay: TSH
Catalogue Number: K6412
Siemens Material Number (SMN): 10445104
Lot Number: 14237AA
ARTG number : 180109 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has determined that Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce results with a negative bias ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well. The occurrence of this issue is low. Quality Control will detect the issue if it is run near the end of an affected well set.
The potential for clinical impact as a result of this issue is limited to a delay in hypothyroidism investigations. When this issue occurs, it is likely the negatively biased TSH values will not correlate reciprocally with free or total thyroid hormone values. In cases of monitoring TSH suppression for thyroid cancer, the potential for clinical misinterpretation of a patient’s response to thyroid hormone replacement therapy exists. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is instructing customers to discontinue and discard remaining inventory of the affected lot as a result of this issue. A look back at the previously generated results using the affected lot is recommended provided the sample is within the specified storage conditions and time, and where a TSH value within or below the reference interval did not reciprocally correlate with free or total thyroid hormone values. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |