Medical Device Recall: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Abbott Laboratories · February 21, 2024
Reason for 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.
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, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Mali, Mexico, Morocco, Poland, Portugal, Peoples Republic of China, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Switzerland, Taiwan, Tajikistan, Tanzania, Trinidad & Tobago, Turkey, Uganda, Uruguay, Uzbekistan, and Vietnam.
States Affected
NATIONWIDE
Quantity Affected
7482 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1476-2024
Status: ongoing
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