Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1240-2016 — 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

U.S. FDA — Device Enforcement · United States · 2016-01-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1240-2016
Date of alert: 2016-01-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10490889

Reported risk: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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