Roche Diagnostics Operations, Inc.: 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

Is my product affected?

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, label

• UPC 06656021190

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

What happened

Roche Diagnostics Operations, Inc. is recalling Estradiol III reagent kits used with Elecsys and cobas e analyzers nationwide, including Puerto Rico. The recall affects 23,630 units across all lot numbers of product REF 06656021190. The company identified a cross reactivity problem: when the Elecsys Estradiol assay is used to monitor patients being treated with fulvestrant, the test produces falsely elevated estradiol concentration readings because fulvestrant interferes with the test results.

Due to this cross reactivity, the Elecsys Estradiol assay should not be used for monitoring patients on fulvestrant therapy. Roche has notified customers that fulvestrant will artificially increase apparent estradiol levels in women taking this drug. The recall notice indicates that some patients may have had their fulvestrant treatment altered or discontinued based on these false test results. The source document does not specify a remedy or corrective action for affected consumers.

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: 23,630 Lot/code info: Elecsys Estradiol III: 06656021190; 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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