Abbott recalls estradiol reagent kits that may show falsely high hormone levels for patients using mifepristone. Affected kits include specific lot numbers across multiple product lines.
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 estradiol reagent kits that could show falsely elevated hormone levels for patients using mifepristone. This affects patients currently or recently treated with the drug, potentially leading to incorrect medical decisions.
The reagent kit may produce false high estradiol results for patients using mifepristone. This could lead to incorrect medical decisions if the false results are interpreted as real hormone levels.
Patients currently or recently treated with mifepristone may be affected. Those using the recalled estradiol reagent kits for hormone testing are most at risk.
Check for lot numbers 7K72-20, 7K72-25, or 7K72-35 on the reagent kit packaging. These kits are part of Abbott's ARCHITECT Estradiol assay product line.
Look for lot numbers 7K72-20, 7K72-25, or 7K72-35 on the reagent kit packaging.
No, but you should check the lot number to see if it's affected. If it is, contact Abbott for guidance.
The test may show higher hormone levels than actual, which could lead to incorrect medical decisions for patients using mifepristone.
Check the lot number on the packaging; affected kits have lot numbers 7K72-20, 7K72-25, or 7K72-35.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1353-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1353-2019 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.
