| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00039-1 |
| Product Name/Description |
ADVIA Centaur, Dimension Vista & Immulite Systems
Assay: ADVIA Centaur Progesterone
Test Code: PRGE
Catalogue/SMN # 10310305, 10315522, 10333111
Assay: Dimension Vista LOCI Progesterone
Test Code: PROG
Catalogue: K6464
SMN: 10461743
Assay: Immulite/Immulite 1000 Progesterone
Test Code: PRG
Catalogue: LKPW1
SMN: 10381128
Assay: Immulite 2000 Progesterone
Test Code: PRG
Catalogue: L2KPW2, L2KPW6
SMNs: 10381181, 10381170
All Lots
ARTG # 175698, 180109, 179720 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has confirmed that the presence of DHEA-S (a metabolite of DHEA, a steroid hormone that may be used as part of in vitro fertilisation (IVF) protocols to improve ovarian response and IVF treatment outcomes) causes falsely elevated progesterone results on certain platforms around the clinically important decision level of approximately 1 ng/mL (3.18 nmol/L) of progesterone. This threshold is used by some IVF protocols to determine whether to proceed with fresh embryo transfer in the current cycle. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Affected assays should not be used to report results for patients who are taking DHEA supplements.
For patients taking DHEA supplements, an alternate method such as Liquid Chromatography-Mass Spectroscopy (LCMS) which is not expected to show cross reactivity to DHEA-S should be used to measure progesterone concentrations.
Siemens’ Progesterone assays may continue to be used to report results for patients who are not taking DHEA supplements.
A review of previously generated results is at the discretion of the laboratory.
This action has been closed out on 10/07/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |