Lower risk Medical device recall · FDA · Published February 21, 2024

Abbott ARCHITECT STAT Myoglobin Reagent Kit Recall: Incorrect Myoglobin Results Risk

Abbott recalls ARCHITECT STAT Myoglobin Reagent Kits with specific lot numbers due to potential incorrect myoglobin test results, risking delayed heart attack diagnosis.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1476-2024Medical device Abbott ›

Lower-risk recall

The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.

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Contact the company

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

✎ GovInfoNow plain-language explainer

Abbott is recalling two specific models of myoglobin reagent kits because a manufacturing issue could cause incorrect test results. This might delay diagnosing heart attacks, which is serious but not immediately life-threatening. Read more at govinfonow.com/recall/56121-abbott-architect-stat-myoglobin-reagent-kit-recall-incorrect-myoglobin-results.

Source Summary by GovInfoNow · govinfonow.com/recall/56121-abbott-architect-stat-myoglobin-reagent-kit-recall-incorrect-myoglobin-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1476-2024

Cite this page

“Abbott ARCHITECT STAT Myoglobin Reagent Kit Recall: Incorrect Myoglobin Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56121-abbott-architect-stat-myoglobin-reagent-kit-recall-incorrect-myoglobin-results. Based on FDA recall #Z-1476-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1476-2024%22&limit=1).

The FDA announced on Feb. 21, 2024, that Abbott Laboratories is recalling ARCHITECT STAT Myoglobin Reagent Kits due to manufacturing issues that may lead to incorrect results and delayed diagnosis of myocardial infarction. The agency issued recall number Z-1476-2024 for the Class II voluntary recall.

How to tell if you have it

ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-20
Lot numbers 50808UN23 and 60104UN23
UPC 00380740003296 and UPC 00380740003302

The hazard

The recall is due to the failure of calibration and quality controls caused by microparticles not meeting labeled claims. This manufacturing issue may lead to incorrect myoglobin results, which could delay the diagnosis of myocardial infarction.

Context

GovInfoNow's records show Abbott Laboratories has issued 33 other recalls since May 14, 2012. Recent Abbott recalls include a Nov. 13, 2025, correction for the Alinity ci-series System Control Module and a Sept. 18, 2025, software issue with the Alinity hq Analyzer. Other recent recalls of similar products include the ID NOW Influenza A & B 2 Kit (Feb. 9, 2026) and i-STAT EG6+ Cartridges (April 1, 2026).

How to tell if you have this one

Check for lot numbers 50808UN23 (expiring 11/30/2024) or 60104UN23 (expiring 11/30/2024) on the reagent kits. The kits are labeled as ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 or 2K43-20.

Brand
Abbott
Product
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for lot numbers 50808UN23 or 60104UN23 on the reagent kit packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 20 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IL, KS, LA, MI, MO, MS, NE, NY, OH, OR, PA, TX, VA, and WI. The countries of Angola, Austria, Belarus, Belgium, Brazil, Czech Republic, France, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, Mississippi, Missouri, Nebraska, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin.

Recall timeline

FDA published this recall 49 days after the firm started it.

Feb 21, 2024Firm started the recall
Apr 4, 2024FDA classified it Class II
Apr 10, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56121-abbott-architect-stat-myoglobin-reagent-kit-recall-incorrect-myoglobin-results">Abbott ARCHITECT STAT Myoglobin Reagent Kit Recall: Incorrect Myoglobin Results Risk (GovInfoNow)</a>

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-1476-2024 (February 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1476-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.