DiaSorin Recalls LIAISON Estradiol II Gen Assay Due to Cross-Reactivity
DiaSorin is recalling the LIAISON Estradiol II Gen assay because it may produce inaccurate results for patients treated with fulvestrant.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (inaccurate diagnostic results) for a specific patient population, but no injuries or illnesses have been reported.
Plain-English summary
DiaSorin Inc. is issuing an urgent medical device correction for the LIAISON Estradiol II Gen assay. The product is a chemiluminescent immunoassay intended for the quantitative determination of estradiol in human serum. The recall affects 10,739 units distributed nationwide in the United States and in numerous countries worldwide.
The recall is being issued due to a recently identified cross-reactivity risk. Specifically, the assay should not be used to test patients who are being treated with fulvestrant (Faslodex). Using the test on these patients may result in inaccurate clinical data.
Healthcare facilities and laboratories should stop using the LIAISON Estradiol II Gen assay for patients receiving fulvestrant treatment. DiaSorin is managing the correction to ensure the safety and accuracy of diagnostic results.
The recalled product
- 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…
- Manufacturer
- Diasorin Inc.
- Affected units
- 10,739
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number 31 0680
- 31 0680-CN
Distribution
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