ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Reported: April 10, 2024 Initiated: February 21, 2024 #Z-1476-2024
Product Description
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
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.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 7482 kits
- 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.
- Location
- Abbott Park, IL
Frequently Asked Questions
What product was recalled? ▼
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.. Recalled by Abbott Laboratories. Units affected: 7482 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1476-2024.
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