| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00088-1 |
| Product Name/Description |
ADVIA Centaur Systems Progesterone Kits
Test Code: PRGE
Kit Lot Numbers: Ending in 268
Catalogue Numbers: 02382928 (1-pack), 01586287 (5-pack), 02177364 (5-pack Ref)
Expiration Date: May 22, 2015
ARTG Number: 175698 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed a high bias on results greater than 30 ng/mL (95.4 nmol/L) when compared to the master curve when using the affected ADVIA Centaur Progesterone kit lots. The high bias may cause neat serum samples with results greater than 60 ng/mL (190.8 nmol/L) to recover within the assay range upon dilution (dilution factor applied). On the ADVIA Centaur Systems, for samples greater than 30 ng/mL (95.4 nmol/L), customers may observe an average dilution recovery between 48.3% and 105.0%. Samples (both neat and diluted) with values below 30 ng/mL (95.4 nmol/L) do not demonstrate this bias.
Progesterone values above 30 ng/ml (95.4 nmol/L) are indicative of pregnancy. The difference in neat values compared to diluted values will not change the clinical interpretation of the results. Siemens advises that the severity of potential injury is negligible and the overall risk to health is negligible to non-existent. No laboratory look back is recommended. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A workaround is provided to customers regarding dilution of samples for lots ending in 268 only. Technical Specialist contact number details are also provided for users as ongoing support. This action has been closed-out on 06/09/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |