Abbott Alinity i Estradiol Reagent Kit Recalled for False Results
Abbott Ireland Diagnostics Division is recalling Alinity i Estradiol Reagent Kits because patient results may be falsely elevated for individuals treated with Mifepristone.
What this means for you
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 involves a medical device where patient results may be falsely elevated, posing a risk of harm through incorrect clinical decisions, but no injuries or illnesses have been reported.
Plain-English summary
Abbott Ireland Diagnostics Division is recalling the Alinity i Estradiol Reagent Kit, a chemiluminescent microparticle immunoassay used to measure Estradiol in serum and plasma on the Alinity i analyzer. The recall involves 64,618 units of List Number 07P5020 and List Number 07P5030, all lots. The product was distributed worldwide and across the United States, including Puerto Rico.
The recall is being issued because patient results may be falsely elevated. This specific patient impact applies only to patients who are currently being treated with, or have recently been treated with, the drug Mifepristone. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and laboratories should stop using the affected reagent kits and contact Abbott Ireland Diagnostics Division for further instructions. Patients who have had Estradiol tests performed using these kits while taking Mifepristone should consult their healthcare provider to discuss their results.
The recalled product
- Product
- Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
- Manufacturer
- Abbott Ireland Diagnostics Division
- Affected units
- 64,618
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 (1)
- List Number 07P5020 - ALL LOTS and List Number 07P5030 - ALL LOTS.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Abbott Ireland Diagnostics Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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