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Instrumentation Laboratory Co. recalls ACL TOP 300 CTS, automated coagulation laboratory instrument.
Recalled July 23, 2014 · FDA recall Z-2066-2014 · Instrumentation Laboratory
Hazard
Potential for sample misidentification. · FDA Class II
Units
1201
Sold at
Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.
Description
Potential for sample misidentification.
Product
ACL TOP 300 CTS, automated coagulation laboratory instrument.
Manufacturer(s)
Instrumentation Laboratory Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →