Recall Z-0645-2017— Diasorin Inc.
Class II · Terminated
Class II FDA medical device recall by Diasorin Inc., initiated 2016-07-13, terminated 2017-12-27. FDA's recall record names no specific 510(k) clearance for this event. 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: 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)..
- Recalling firm
- Diasorin Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-13
- Terminated
- 2017-12-27
- Firm location
- Stillwater, MN, United States
Product description
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).
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