CLASS II Device recall · Reported 30 Nov 2016 · FDA Enforcement Report

Liaison Estradiol II Gen recalled by Diasorin

Diasorin is recalling Liaison Estradiol II Gen, 310680, 310680-CN The DiaSorin Liaison Estradiol II Gen assay, distributed nationwide in the US. The recall was initiated on 13 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number 31 0680, 31 0680-CN

Quantity recalled10,739

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0645-2017
FDA event ID: 75478
Recalling firm: Diasorin, Stillwater, MN
Classification: Class II
Status: Terminated
Recall initiated: 13 Jul 2016
FDA classified: 21 Nov 2016
Reported: 30 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

13 Jul 2016	Recall initiated by company
21 Nov 2016	Classified by FDA	+131 days
30 Nov 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. Due to the risk of a recently identified cross reactivity, the LIAISON¿ Estradiol II Gena assay should not be used to test patients being treated with fulvestrant (Faslodex).

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family.

Where it was distributed

USA (nationwide) Distribution and Worldwide Distribution including the states of : AR, AZ, CA, FL, ID, NJ, NV, NY and PA.., and to the countries of : Saudi Arabia, Colombia, Mauritius, Iraq, Mongolia, Greece, Albania, Austria, Bosnia, Bosnia Herzegovina, Belarus, Bulgaria, Macedonia, Poland, Serbia, Dominican Rep., Tunisia, Paraguay, Hungary, Jordan, Egypt, Belgium, Caribbean, Germany, Brazil, Mexico, Italy, India, South Korea, Cyprus, Bangladesh, Morocco, Chile, Bahrain, Palestine, Utd.Arab.Emir., Kosovo, Uruguay, Venezuela, Hungary, Australia, Vietnam, Sri Lanka, Turkey, Vietnam, Romania, Mauritius, Ecuador, Lebanon, Nepal, Argentina, Hong Kong, China and Canada.

Nationwide Arkansas Arizona California Florida Idaho New Jersey Nevada New York Pennsylvania

Questions about this recall

Is Liaison Estradiol II Gen, 310680, 310680-CN The DiaSorin Liaison Estradiol II Gen assay recalled?

Yes. Diasorin recalled Liaison Estradiol II Gen, 310680, 310680-CN The DiaSorin Liaison Estradiol II Gen assay on 13 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-0645-2017.

Why was it recalled?

Which lots are affected?

Catalog Number 31 0680, 31 0680-CN

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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