Z-1277-2016 Class II Terminated
FDA device recall Z-1277-2016 was initiated by Roche Diagnostics Operations, Inc. on Mar 7, 2016 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 10, 2018). Affected quantity: 102,312.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 6, 2016
- Initiation Date
- Mar 7, 2016
- Termination Date
- Jan 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102,312
Product Description
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.
Reason for Recall
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
Distribution Pattern
US Nationwide Distribution including Puerto Rico.
Code Information
Part Number Elecsys Estradiol II : 03000079190; all lot numbers are affected.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1277-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026