Abbott recalls ARCHITECT STAT Myoglobin Reagent Kits with specific lot numbers due to potential incorrect myoglobin test results, risking delayed heart attack diagnosis.
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.
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.
The reagent kits contain microparticles that don't meet quality standards, leading to inaccurate myoglobin measurements. Incorrect results might delay detecting heart attacks, but the risk is not immediate or life-threatening.
Healthcare professionals using these kits for cardiac tests are most at risk. Patients relying on these tests for heart attack diagnosis could face delayed care.
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.
Look for lot numbers 50808UN23 or 60104UN23 on the reagent kit packaging.
The recall is due to a manufacturing issue causing microparticles to not meet quality standards, which may lead to incorrect myoglobin test results and delayed heart attack diagnosis.
The official notice does not specify a remedy, so check the lot number and contact Abbott for guidance.
The recall indicates a risk of incorrect results, but the hazard is not immediate or life-threatening. The risk level is low.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1476-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1476-2024 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.
