Abbott recalls ARCHITECT Free T3 Reagent Kits for potential depressed test results when used on specific ARCHITECT platforms. Affected kits may cause inaccurate thyroid hormone measurements.
Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms.
Abbott is recalling ARCHITECT Free T3 Reagent Kits used on ARCHITECT i1000SR or i2000/i2000SR platforms. These kits may cause test results to show lower than actual thyroid hormone levels due to reagent carryover between tests.
When multiple thyroid hormone tests are run in quick succession on the same platform, reagent carryover can cause the test results to show lower than actual thyroid hormone levels. This may lead to incorrect diagnosis or treatment decisions.
Healthcare facilities using Abbott's ARCHITECT Free T3 Reagent Kits on specific laboratory platforms are affected. Patients receiving thyroid hormone tests may be at risk of inaccurate results.
Check if your kit has list numbers 7K63-20, 7K63-25, 7K63-27, 7K63-30, 7K63-35, 7K63-32, or 7K63-37. The recall includes all lot codes for these list numbers.
Identify your kit's list number from the product description to confirm if it's affected.
The recall is due to potential depressed test results when multiple thyroid hormone tests are run in quick succession on the same platform.
Tests may show lower than actual thyroid hormone levels, which could affect diagnosis and treatment decisions.
Check if your kit has list numbers 7K63-20, 7K63-25, 7K63-27, 7K63-30, 7K63-35, 7K63-32, or 7K63-37.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0798-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0798-2019 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.
