Abbott C4 Diagnostic Assay Recall: Update Needed for Safety

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Recalling firmAbbott Laboratories, Inc1921 Hurd Dr, N/A · Irving, TX 75038-4313

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Abbott is recalling C4 diagnostic assay kits that require updated instructions for safe handling. This recall is needed to address potential issues with how the products are used.

Why it’s dangerous

The assay requires specific handling procedures to ensure accurate results. Without updated instructions, there could be errors in the testing process.

Who’s affected

Healthcare professionals and lab staff who use C4 diagnostic assays are likely affected. Those handling the kits without updated instructions face the highest risk.

How to tell if you have this one

Check for C4 diagnostic assay kits from Abbott Laboratories. The product is used for measuring C as an antigen in blood samples.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Review Instructions
Check if your C4 kit has updated instructions for safe handling as per the recall notice.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

Abbott requires updated instructions for safe handling due to different issues with the products.

Do I need to stop using this product?

No, but you must review the updated instructions to ensure safe handling.

What should I do if I have this product?

Review the updated instructions for safe handling; no action is needed beyond this step.

Take action

Contact Abbott

We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1992-2019 — Abbott Abbott

Hello,

I own a Abbott that is covered by recall Z-1992-2019 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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Where this comes from

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.

Official source: FDA Recall #Z-1992-2019 (May 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1992-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Abbott Laboratories, Inc recalls C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the

Lower-risk recall