FDA Medical Device Recalls (openFDA)
Diasorin Inc.: 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.
- Recall number
- Z-0645-2017
- 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.
- Status
- Terminated
- Initiated
- 2016-07-13
- Posted
- not on file
- Terminated
- 2017-12-27
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Catalog Number 31 0680, 31 0680-CN
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CHP
- Firm FEI
- 2182595
- Firm city
- Stillwater
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28