The Recall Desk

FDA (Devices) recall action 73411

Roche Diagnostics Operations, Inc. recalled 2 products on 2016-04-06

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-04-06
Critical
0
Units
125,942

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2016-04-06

    Roche Estradiol II Assay Recalled Due to Fulvestrant Cross-Reactivity

    Roche Diagnostics is recalling the Elecsys Estradiol II assay because fulvestrant treatment causes falsely elevated estradiol results.

    Product
    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 derivativ
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-04-06

    Roche Estradiol III Assay Recalled Due to Fulvestrant Cross-Reactivity

    Roche is recalling the Estradiol III assay because fulvestrant treatment causes falsely elevated estradiol results, potentially leading to incorrect patient management.

    Product
    Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2 Estr
    Category
    Distribution
    1 state