Abbott ARCHITECT Estradiol Reagent Kit Recall for Mifepristone Interference
Abbott is recalling ARCHITECT Estradiol Reagent Kits because patient results may be falsely elevated for individuals currently or recently 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 specific injuries or illnesses are reported in the source text.
Plain-English summary
Abbott Ireland Diagnostics Division is recalling 2,724 units of the ARCHITECT Estradiol Reagent Kit. The recall covers List Numbers 7K72-20, 7K72-25, and 7K72-35, all lots. The product is a Chemiluminescent Microparticle Immunoassay (CMIA) used for the quantitative determination of Estradiol in human serum and plasma.
The recall was initiated 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 affected products were distributed worldwide, including nationwide distribution in the United States and Puerto Rico, as well as in numerous international countries. Healthcare facilities and laboratories should stop using the affected reagent kits and contact Abbott for further instructions.
The recalled product
- Product
- Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
- Manufacturer
- Abbott Ireland Diagnostics Division
- Affected units
- 2,724
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 (3)
- List Number 7K72-20 - ALL LOTS
- List Number 7K72-25 - ALL LOTS
- and List number 7K72-35 - 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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