Recall Z-0645-2017 ยท CHP Radioimmunoassay, Estradiol
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
| Date | Jul 13, 2016 |
| Status | Terminated |
| 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, Ser |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.