Abbott Laboratories is recalling 7,482 ARCHITECT STAT Myoglobin Reagent Kits due to a manufacturing defect in the microparticles used in the test. This defect causes the kits to fail quality and calibration controls, which can lead to inaccurate myoglobin test results. These kits were distributed worldwide, including 20 U.S. states, and were manufactured in the United States. Because these tests are used to help diagnose serious heart conditions, incorrect results could lead to a delayed diagnosis of a heart attack (myocardial infarction).
The failure of the microparticles to meet labeled specifications can result in falsely low or incorrect myoglobin measurements. This directly interferes with a clinician's ability to accurately diagnose a heart attack in a timely manner, potentially delaying life-saving medical intervention.
Manufacturing and calibration failure correction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.