Abbott recalls Alinity i Anti-TPO Reagent Kit (List 09P3521) due to a fill volume error that may affect test accuracy. Affected units have specific lot numbers and expiration dates.
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Abbott is recalling Alinity i Anti-TPO Reagent Kits with a fill volume error that could lead to inaccurate test results. This affects kits sold with specific lot numbers and expiration dates.
The reagent kit contains a marginally lower fill volume than stated in the instructions, which could cause inaccurate test results. This error does not pose a physical danger but may lead to incorrect health assessments.
Users of the Alinity i Anti-TPO Reagent Kit with Lot Number 46009FN00 and Expiration Date 07/20/2024 are affected. Most at risk are healthcare providers using the kit for thyroid tests.
Check for Lot Number 46009FN00 and Expiration Date 07/20/2024 on the kit's packaging. The product was sold with List Number 09P3521.
Verify the lot number and expiration date on the kit's packaging to confirm if it's affected.
No, the recall is for potential inaccurate test results, not a physical hazard. The risk is low and does not involve injury.
Check for Lot Number 46009FN00 and Expiration Date 07/20/2024 on the kit's packaging. The product was sold with List Number 09P3521.
The recall does not specify a remedy, so contact Abbott directly for guidance on next steps.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1696-2023 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1696-2023 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.
