Abbott ARCHITECT STAT Troponin-I Calibrators Recalled Due to Missing Dry Ice

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Recalling firmAbbott Laboratories100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL 60064-3502

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Abbott is recalling ARCHITECT STAT High Sensitive Troponin-I Calibrators that were shipped without the required dry ice. This could lead to inaccurate test results if used in cardiac troponin I testing.

Why it’s dangerous

The calibrators were delivered without dry ice, which is necessary for proper storage and handling. Without dry ice, the calibrators may become unstable or inaccurate, leading to incorrect test results in cardiac troponin I testing.

Who’s affected

Lab users who purchased these calibrators for cardiac troponin I testing are affected. The risk is low as the hazard is related to shipping conditions, not direct harm.

How to tell if you have this one

Check for the product name 'ARCHITECT STAT High Sensitive Troponin-I Calibrators' and lot number 93284UIOO. These were sold by Abbott Laboratories.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name and lot number to confirm if your calibrators are affected.

✎ GovInfoNow

Questions people ask

Why were the calibrators recalled?

The calibrators were delivered without the required dry ice, which is necessary for proper storage and handling.

What should I do if I have the recalled calibrators?

Contact Abbott Laboratories for details on how to handle the affected products.

Is there a risk of injury from using these calibrators?

No, the hazard is related to potential inaccurate test results, not direct injury.

Take action

Contact Abbott

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

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Subject: Recall Z-1360-2019 — Abbott Abbott

Hello,

I own a Abbott that is covered by recall Z-1360-2019 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-1360-2019 (April 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1360-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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 recalls ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I

Lower-risk recall