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Recall Observatory FDA recall evidence

Device product

ACL TOP CTS, automated coagulation laboratory instrument.

Z-2062-2014

June 03, 2014

Class II

Product summary

Firm
Instrumentation Laboratory Co.
Event
Event 68578
Status
Terminated
Classification
Class II
Quantity
572
Official record key
device-enforcement:Z-2062-2014

Official wording

Reason: Potential for sample misidentification.

Code information: Start SN and Date: 06020101 Feb 2006 End SN and Date 10080662 Aug 2010

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for sample misidentification.