Abbott recalls all lots of Alinity i Estradiol Reagent Kit due to potential false elevated hormone results for patients using mifepristone. Affected users should contact Abbott for guidance.
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Abbott is recalling all lots of its Alinity i Estradi:ol Reagent Kit because it may give false high estradiol results for patients using mifepristone. This could lead to incorrect treatment decisions if the test is used without knowing the patient's medication history.
The test may show higher estradiol levels than actual in patients taking mifepristone. This could cause incorrect treatment decisions if the false high results are not recognized.
Patients currently being treated with or recently treated with mifepristone may be affected. Those using the test without knowing their medication history are at higher risk.
The product is the Abbott Alinity i Estradiol Reagent Kit. All lots (List Numbers 07P5020 and 07P5030) are affected.
Reach out to Abbott directly for specific guidance on next steps.
No, the risk only applies to patients currently being treated with or recently treated with mifepristone.
Look for the product name 'Abbott Alinity i Estradiol Reagent Kit' and list numbers 07P5020 or 07P5030 on all lots.
The recall does not require immediate stop use; contact Abbott for specific guidance.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1354-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1354-2019 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
