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

Recall Z-1277-2016 — Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL; R1 Biotinylated polyclonal anti-estradiol antibody (rabbit) 45 ng/mL; Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruth

U.S. FDA — Device Enforcement · United States · 2016-03-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1277-2016
Date of alert: 2016-03-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Roche Diagnostics Operations, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 03000079190

Reported risk: Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant. Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. If treatment with fulvestrant has been altered or discontinued as a result of falsely elevated e

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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