Abbott recalls ALINITY i Anti-TPO Calibrators delivered without required dry ice. This affects lab equipment used for thyroid antibody testing. No remedy is specified in the recall notice.
Devices were delivered without the required dry ice.
Abbott is recalling ALIN:ITY i Anti-TPO Calibrators that were shipped without the required dry ice. This could cause improper calibration of thyroid antibody tests, potentially leading to inaccurate results.
The calibrators require dry ice for proper storage and stability. Without dry ice, the calibration may become inaccurate, leading to unreliable thyroid antibody test results.
Lab technicians and healthcare facilities using the ALINITY i Anti-TPO Calibrators for thyroid antibody testing. Those handling the equipment without dry ice are at risk of inaccurate test results.
Check for the model number LN 09P3501 and lot number 84347UN18 on the product packaging. These calibrators were delivered without the required dry ice.
Look for the model number LN 09P3501 and lot number 84347UN18 on the packaging to confirm if the product is affected.
The recall states the devices were delivered without the required dry ice, which is necessary for proper storage and calibration stability.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the model and lot numbers listed.
The recall does not indicate a need to stop using the product, but improper calibration without dry ice could lead to inaccurate test results.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1361-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1361-2019 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.
