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U.S. Department of Health and Human Services

Class 2 Device Recall ACL TOP 500 CTS

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  Class 2 Device Recall ACL TOP 500 CTS see related information
Date Initiated by Firm June 03, 2014
Date Posted July 16, 2014
Recall Status1 Terminated 3 on September 21, 2017
Recall Number Z-2064-2014
Recall Event ID 68578
510(K)Number K091980  K033141)  
Product Classification Instrument, coagulation, automated - Product Code GKP
Product ACL TOP 500 CTS, automated coagulation laboratory instrument.
Code Information Start SN and Date: 08010100 Jan 2008 End SN and Date 14052901 May 2014
Recalling Firm/
Manufacturer		 Instrumentation Laboratory Co.
180 Hartwell Road
Bedford MA 01730-2443
For Additional Information Contact
800-678-0710
Manufacturer Reason
for Recall		 Potential for sample misidentification.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified via phone starting on June 3, 2014. On June 4, a USPS mailing was sent to all US/Canadian customers. On June 4, 2014, email notifications were sent to the IL Affiliates and International Distributors/Dealers (through the International Group) requesting them to translate the Field Safety Notice and provide notification to their customer base and secondary distributors. The Urgent Product Correction letter informs consignees of the issue and provides workaround instructions. Consignees are asked to complete a Mandatory Response Tracking Record and return it via Fax (781)861-4207 or email: ra-usa@ilww.com. For technical questions, consignees should contact the IL Technical Support Center at 1-800-678-0710.
Quantity in Commerce 2802
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GKP and Original Applicant = INSTRUMENTATION LABORATORY CO.
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