—#144234

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 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.

FDA product code: CHP — Radioimmunoassay, Estradiol
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Part Number Elecsys Estradiol II : 03000079190; all lot numbers are affected.

Why it was 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

Root cause (FDA determination)

Device Design

Action the firm took

Roche sent an Urgent Medical Device Correction letter dated March 7, 2016 via UPS Ground (receipt required) to the consignee list. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to complete the attached fax form and fax it to 1-866-891-1984. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: US Nationwide Distribution including Puerto Rico.

Timeline

Recall initiated: 2016-03-07
Terminated: 2018-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144234. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.