ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Enforcement
- Recall Number
- Z-1476-2024
- Event ID
- 94149
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abbott Laboratories
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 10, 2024
- Initiation Date
- February 21, 2024
- Classification Date
- April 4, 2024
- Address
- 100 Abbott Park Rd Bldg Ap8b, Abbott Park, IL, 60064-3502, United States
Description
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
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.
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.
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.
7482 kits