Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: Firm is initiating a removal due to continued reports of adverse events.
Distributed: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Reason: A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Distributed: International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.Reason: The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
Distributed: Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.Reason: Pumps were released without full testing being performed, including occlusion alarm testing.
Distributed: States: Ohio Countries: United StatesReason: Due to damage to outer tray that can potentially compromise the sterile barrier
Distributed: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.