HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Official notice from a government agency or its published feed.
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Class IThe FDA's most serious recall level: a reasonable chance the product could cause serious health problems or death. · Ongoing · Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.
Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Class IThe FDA's most serious recall level: a reasonable chance the product could cause serious health problems or death. · Ongoing · Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.
Hazard: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
View the FDA enforcement report ↗ ← All reports