Abbott recalls ARCHITECT Total T3 Reagent Kits for i1000SR and i2000/i2000SR platforms. Samples may show depressed Free T3 results due to reagent carryover when testing on specific platforms.
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 Total T3 Reagent Kits used with certain laboratory analyzers. These kits may cause test results to show lower than actual Free T3 levels when used with specific platforms, potentially affecting thyroid hormone testing accuracy.
When testing on the ARCHITECT i1000SR or i2000/i2000SR platforms, reagent carryover between tests can cause Free T3 assay results to be lower than they should be. This may lead to incorrect thyroid hormone measurements if the same reagent is used for multiple tests without proper cleaning.
Laboratory users who have ARCHITECT Total T3 Reagent Kits with list numbers 7K64 20 through 7K64 37. Those testing thyroid hormones with these kits are most at risk of inaccurate results.
Check your ARCHITECT Total T3 Reagent Kit list numbers: 7K64 20, 25, 30, 35, 27, 32, or 37. These kits were sold with the ARCHITECT i1000SR or i2000/i2000SR platforms.
Identify your kit's list number from the product label, which should be one of 7K64 20, 25, 30, 35, 27, 32, or 37.
The recall is happening because reagent carryover between tests on specific platforms can cause Free T3 assay results to be lower than actual levels, potentially affecting thyroid hormone testing accuracy.
No, you do not need to stop using these kits. The recall is for accurate testing, not immediate safety risks.
Your kit is affected if it has a list number of 7K64 20, 25, 30, 35, 27, 32, or 37 and was used with the ARCHITECT i1000SR or i2000/i2000SR platforms.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0799-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0799-2019 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.
