FDAFDA · Food and drugs·Recall number Z-2248-2013
ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Published September 25, 2013 · Recall initiated: July 19, 2013
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 carryover issue that can can cause shortened APTT clotting times on the instrument.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumentation Laboratory Co.
- Distributor
- Worldwide Distribution - USA including 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, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.
- Lot
- Start SN and Date: 09120101, Dec 2009; End SN and Date: 13070304, July 2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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