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Recall Observatory FDA recall evidence

Device product

ACL TOP 700 LAS; PN 0000280030 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.

Z-2247-2013

July 19, 2013

Class II

Product summary

Firm
Instrumentation Laboratory Co.
Event
Event 65893
Status
Terminated
Classification
Class II
Quantity
56
Official record key
device-enforcement:Z-2247-2013

Official wording

Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

Code information: Start SN and Date: 08120100, Dec 2008; End SN and Date: 13070172, July 2013

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential carryover issue that can can cause shortened APTT clotting times on the instrument.