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Recall Observatory FDA recall evidence

Device product

ACL TOP 700 LAS, automated coagulation laboratory instrument.

Z-2063-2014

June 03, 2014

Class II

Product summary

Firm
Instrumentation Laboratory Co.
Event
Event 68578
Status
Terminated
Classification
Class II
Quantity
99
Official record key
device-enforcement:Z-2063-2014

Official wording

Reason: Potential for sample misidentification.

Code information: Start SN and Date: 08120100 Dec 2008 End SN and Date 14050198 May 2014

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.