Estradiol III — Class II medical device recall Z-1276-2016
Terminated recall by Roche Diagnostics Operations, Inc., reported 2016-04-06, distributed nationwide. Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when
| Recall number | Z-1276-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2016-03-07 |
| Classified | 2016-03-31 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2018-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 23,630 |
| Reason classes | potency |
| Model numbers | 06656021, 190 |
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 Estradiol derivative, labeled with ruthenium complex 4.5 ng/mL; Rx only 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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.