Roche Diagnostics Operations, Inc.: 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 Bi

Is my product affected?

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 derivative, labeled with ruthenium

• UPC 03000079190

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Operations, Inc. is recalling the Elecsys Estradiol II assay used with Elecsys and cobas e analyzers due to a cross reactivity with fulvestrant, a drug used to treat certain patients. The assay should not be used to monitor patients being treated with fulvestrant because the drug causes falsely elevated estradiol concentration readings. All lot numbers of the product (Part Number 03000079190) are affected, and approximately 102,312 units were distributed nationwide in the United States, including Puerto Rico.

The source document does not specify what an affected consumer should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Distribution: US Nationwide Distribution including Puerto Rico. Quantity: 102,312 Lot/code info: Part Number Elecsys Estradiol II : 03000079190; all lot numbers are affected.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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