Abbott recalls transferrin diagnostic assays requiring IFU updates due to handling issues. Learn what to do if you have this product.
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 transferrin diagnostic assays that need updated instructions for safe use. This recall is about improving handling procedures to prevent potential errors in testing.
The test requires specific handling steps to avoid errors. Without updated instructions, there's a risk of incorrect results due to improper sample preparation or reagent handling.
Healthcare professionals and labs using transferrin diagnostic tests may be affected. Those handling the samples without updated instructions are at slightly higher risk.
This product is an in vitro diagnostic assay for transferrin in human serum or plasma. It was sold by Abbott Laboratories, Inc. Check if your test kit has outdated instructions.
Verify if your test kit has outdated instructions by reviewing the manufacturer's guidelines.
Abbott requires updated instructions for safe handling to prevent potential errors in transferrin testing.
No, but you should check if your instructions are outdated and follow the updated guidelines.
Review the manufacturer's instructions for updates; no action is needed if instructions are current.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1995-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1995-2019 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.
