FDAFDA · Food and drugs·Recall number Z-2064-2014
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Published July 23, 2014 · Recall initiated: June 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for sample misidentification.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Instrumentation Laboratory Co.
- Distributor
- 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.
- Lot
- Start SN and Date: 08010100 Jan 2008 End SN and Date 14052901 May 2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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