FDAFDA · Food and drugs·Recall number 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 ruthenium complex 2.75 ng/mL Product Usage: Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
Published April 6, 2016 · Recall initiated: March 7, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- US Nationwide Distribution including Puerto Rico.
- Lot
- Part Number Elecsys Estradiol II : 03000079190; all lot numbers are affected.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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