Agency classClass IIOur severity:High FDA (Devices)·Z-1276-2016·Announced 2016-04-06

Roche Estradiol III Assay Recalled Due to Fulvestrant Cross-Reactivity

Roche is recalling the Estradiol III assay because fulvestrant treatment causes falsely elevated estradiol results, potentially leading to incorrect patient management.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 diagnostic) where the hazard is incorrect clinical management due to false results, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling the Elecsys Estradiol III assay (REF 06656021 190) used on Elecsys and cobas e analyzers. The recall involves 23,630 units distributed nationwide in the US, including Puerto Rico. All lot numbers are affected.

The recall is due to a recently identified cross-reactivity where the drug fulvestrant increases the apparent concentration of estradiol in women being treated with it. This can result in falsely elevated estradiol levels. The source text indicates that if treatment with fulvestrant has been altered or discontinued as a result of these falsely elevated results, the recall is necessary to prevent incorrect clinical decisions.

Customers should be informed that fulvestrant will increase the apparent concentration of estradiol. The assay should not be used when monitoring patients being treated with fulvestrant.

The recalled product

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…
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: cross-reactivity
false-positive
Affected units: 23,630

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)

Elecsys Estradiol III: 06656021190
all lot numbers are affected.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Roche Diagnostics Operations, Inc.

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Same hazard · cross reactivity