[Recalled] Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparin
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centau |
|---|---|
| Brand / manufacturer | Siemens Healthcare Diagnostics, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1240-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 13 January 2016 |
| EAN / barcode | 10490889 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Siemens Healthcare Diagnostics, Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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