FDA Device recall Z-1276-2016
Estradiol III
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of Estradiol III by Roche Diagnostics Operations, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1276-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-07 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
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
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
Identifiers
| code_info | Elecsys Estradiol III: 06656021190; all lot numbers are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1276-2016%22
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