Abbott recalls C3 diagnostic assay for updated instructions to prevent errors in blood testing. No immediate action needed but review instructions.
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Abbott has recalled its C3 diagnostic assay product due to outdated instructions that could lead to inaccurate test results. This recall does not involve immediate safety risks but requires updating the user manual for proper testing.
The assay instructions were outdated, which could cause inaccurate test results if not updated. This does not pose a direct safety risk but affects test accuracy.
Healthcare professionals using the C3 diagnostic assay for blood tests may need to update their instructions. Patients using this test are not directly affected.
The C3 diagnostic assay for measuring C3 levels in blood. This product was sold with outdated instructions that require updating.
Check if your C3 diagnostic assay has outdated instructions that need updating.
No, this recall is for updated instructions to ensure accurate test results, not a safety hazard.
No, you can continue using it but must update the instructions as per the recall.
The C3 diagnostic assay for measuring C3 levels in blood with outdated instructions.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1987-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1987-2019 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.
