FDAFDA · Food and drugs·Recall number Z-1476-2024
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Published April 10, 2024 · Recall initiated: February 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Laboratories
- Distributor
- 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.
- Lot
- LN 2K43-25 - Lot number 50808UN23, exp. 11/30/2024, UDI (01)00380740003302 (17)241130(10)50808UN23; LN 2K43-20 - Lot number 60104UN23, exp. 11/30/2024, UDI (01)00380740003296 (17)241130(10)60104UN23.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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