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U.S. Department of Health and Human Services

Class 2 Device Recall Automated Coagulation Analyzer

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  Class 2 Device Recall Automated Coagulation Analyzer see related information
Date Initiated by Firm August 03, 2012
Date Posted September 14, 2012
Recall Status1 Terminated 3 on October 02, 2015
Recall Number Z-2391-2012
Recall Event ID 62894
510(K)Number K091980  
Product Classification Instrument, coagulation, automated - Product Code GKP
Product Instrumentation Laboratory ACL TOP 500 CTS
PN 0000280040

ACL TOP is a 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 Serial Number range: 08010100 through 12062270 Distributed between: Jan 2008 to Jun 2012 
Recalling Firm/
Manufacturer		 Instrumentation Laboratory Co.
180 Hartwell Road
Bedford MA 01730-2443
For Additional Information Contact Same
781-861-4467
Manufacturer Reason
for Recall		 Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
FDA Determined
Cause 2		 Software design
Action The firm, Instrumentation Laboratory, sent a "Mandatory Test Parameter Upgrade" letter dated June 7, 2012 with upgrade kits P-14.8 via USPS on August 3 thru August 10 to US and Canadian customers and notified International Affiliates via e-mail on August 2, 2012. The customers were ask to complete and return the Mandatory Test Parameter Upgrade Tracking Form via fax: 781-861-4207 or email: ra-usa@ilww.com. If you have any questions, call 781-861-4204.
Quantity in Commerce 2171 units
Distribution Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and 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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