FDA-Device2024-04-10Class II
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Abbott Laboratories
Hazard
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.
Sold states
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.
Affected count
7482 kits
Manufactured in
100 Abbott Park Rd Bldg Ap8b, Abbott Park, IL, United States
Products
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1476-2024Don't want to check this manually?
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