Abbott recalls Apolipoprotein A1 diagnostic test kits requiring IFU updates due to safety concerns. Learn what to do if you have the kit.
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Abbott is recalling Apolipoprotein A1 diagnostic test kits because their user instructions need updates to address safety issues. This recall does not involve stopping use but requires reviewing the latest instructions to ensure proper handling.
The test kit requires updated instructions to handle samples safely. Without the updates, there could be errors in results or improper handling, but this does not cause immediate harm.
People using Apolipoprotein A1 diagnostic test kits for blood testing may be affected. Those with the latest version of the instructions are at lower risk.
Check for the Apolipoprotein A1 test kit from Abbott Laboratories. The recall applies to all versions with outdated instructions.
Check for the latest version of the instructions to ensure safe use of the test kit.
No, the recall requires updated instructions but does not require stopping use.
Review the latest instructions from Abbott to ensure proper handling.
This recall is low risk as it only requires updated instructions to prevent potential errors in results.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1991-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1991-2019 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.
