Reported Nov 30, 2016 · Terminated
LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent…
Diasorin Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diasorin Inc. · 1951 Northwestern Ave S · Stillwater, MN · 55082-7536
Is this the product you have?
- 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.
- Lot codes and dates
Catalog Number 31 068031 0680-CN
- Amount recalled
- 10,739
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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