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

Recall Z-1241-2016 — Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are used in the diagnosis a

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-1241-2016
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): 10489099

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

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

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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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