Roche Estradiol II Assay Recalled Due to Fulvestrant Cross-Reactivity
Roche Diagnostics is recalling the Elecsys Estradiol II assay because fulvestrant treatment causes falsely elevated estradiol results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is a diagnostic error leading to potential clinical mismanagement, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Elecsys Estradiol II assay (REF 03000079 190) used on Elecsys and cobas e analyzers. The recall involves 102,312 units distributed nationwide in the US, including Puerto Rico. All lot numbers for Part Number 03000079190 are affected.
The recall is due to a recently identified cross-reactivity issue. The assay should not be used when monitoring patients being treated with fulvestrant. Fulvestrant increases the apparent concentration of estradiol in women being treated with this drug, leading to falsely elevated results.
Customers should be informed of this limitation. If treatment with fulvestrant has been altered or discontinued as a result of these falsely elevated results, appropriate clinical review is necessary.
The recalled product
- 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 derivativ
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 102,312
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number Elecsys Estradiol II : 03000079190
- all lot numbers are affected.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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