—#143006

Product

Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.

FDA product code: CHP — Radioimmunoassay, Estradiol
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All lots

Why it was recalled

The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens issued an Urgent Medical Device Correction (UMDC) to affected Siemens Healthcare Diagnostics customers in the United States on January 13, 2016 to be delivered to customers on January 14, 2016 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 13, 2016. The letters identified affected product, problem and the actions to be taken. Customers may continue to use the estradiol assays to report patient results however, the assays should not be used for patients being treated with fulvestrant. Customers where instructed to complete and return the Correction Effectiveness Check attached. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: Worldwide Distribution US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.

Timeline

Recall initiated: 2016-01-13
Terminated: 2018-01-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143006. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.