Z-0645-2017Class II

LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent...

Name: Z-0645-2017 LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent...
Creator: Diasorin Inc.
Published: 2016-07-13
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2016-07-13 / Terminated / root cause: design

FDA source

Diasorin Inc. began a recall of LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative... on 2016-07-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0645-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-13
Posted: 2016-11-21
Terminated: 2017-12-27
Recalling firm: Diasorin Inc.
Product: 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.
Product code: CHP Radioimmunoassay, Estradiol
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).
Root cause tag: design
FDA root cause: Device Design
Action: DiaSorin Inc. sent an Customer Notification letter dated July 13, 2016, to all affected customers. The letter described the problem and the product involved in the recall. The letter listed the "Recommended Actions" and requested customers to complete and return the response portion. For questions contact Product Support at 1-800-328-1482.
Quantity in commerce: 10,739
Distribution: 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.
Product codes and lots: Catalog Number 31 0680, 31 0680-CN

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0645-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0645-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-21

Product code CHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)