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U.S. Department of Health and Human Services

Class 2 Device Recall ACL TOP Family

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 Class 2 Recall
ACL TOP Family
see related information
Date Posted September 18, 2013
Recall Status1 Terminated on October 27, 2014
Recall Number Z-2244-2013
Recall Event ID 65893
Premarket Notification
510(K) Number
K091980 
Product Classification Instrument, Coagulation, Automated - Product Code GKP
Product ACL TOP (Base); PN 0000280000 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.
Code Information Nov 2003 - Nov 2011, Serial Numbers 02110101 through 11111174
Recalling Firm/
Manufacturer
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford, Massachusetts 01730-2443
For Additional Information Contact Carol Marble
781-861-4467
Manufacturer Reason
for Recall
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
FDA Determined
Cause 2
DESIGN: Device Design
Action Instrumentation Laboratory sent an Important Product Correction letter on July 19, 2013, to all affected customers. On July 23, 2013, the same communication was circulated by the IL International Group in Milan, Italy to the affected international distributors and dealers. The interim field notification was followed by the release of corrective Software V5.1.0 and Parameters P-16.3.00 (Phase II) on September 30,2013. Consignees were advised of a potential carryover issue and a workaround was provided. Consignees were asked to fax the Mandatory Response Tracking Form to 781-861-4207 or email to ra-usa.ilww.com For technical questions customers were instructed to contact the IL Technical Support Center at 1-800-678-0710, option 2. For product availability questions, customers were instructed to contact their IL Customer Service Representative at 1-800-955-9525, Option #2. For questions regarding this recall call 781-861-4467.
Quantity in Commerce 929
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GKP and Original Applicant = INSTRUMENTATION LABORATORY CO.
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