Abbott recalls immunoglobulin M diagnostic kits requiring updated instructions due to safety concerns. Users should check if they have the kit and follow official guidance for safe handling.
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 immunoglobulin M diagnostic kits because their instructions need updating to address safety issues. This affects healthcare providers using the test kits for blood analysis.
The test kits require updated instructions to ensure accurate results and safe handling. Without the updates, there could be errors in testing or improper use.
Healthcare providers who use immunoglobulin M diagnostic kits for blood testing are most at risk. The recall applies to kits used in medical settings.
Check if you have immunoglobulin M diagnostic kits for blood testing. The recall applies to all kits that require updated instructions.
Review the instructions for your immunoglob: if they need updating, contact Abbott for the revised version.
The recall requires updated instructions to address safety concerns with the test kits.
No, you can continue using the kit but must follow the updated instructions for safe handling.
Contact Abbott directly for the revised instructions.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1990-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1990-2019 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.
