LIAISON Estradiol II Gen — Class II medical device recall Z-0645-2017
Terminated recall by Diasorin Inc., reported 2016-11-30, distributed nationwide. DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. Due to the ri
| Recall number | Z-0645-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diasorin Inc., Stillwater, MN, United States |
| Recall initiated | 2016-07-13 |
| Classified | 2016-11-21 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-12-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BR, CA, CL, CN, CO, CY, DE, EC, EG, GR, HK, HU, IN, IQ, IT, JO, KR, LB, LK, MA, MX, NP, PL, PY, RO, RS, SA, TN, TR, UY, VE, VN |
| Quantity | 10,739 |
| Reason classes | potency |
| Model numbers | 0680, 0680-CN |
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.
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).
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.