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Class 2 Device Recall Automated Coagulation Analyzer |
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Date Initiated by Firm |
August 03, 2012 |
Date Posted |
September 14, 2012 |
Recall Status1 |
Terminated 3 on October 02, 2015 |
Recall Number |
Z-2388-2012 |
Recall Event ID |
62894 |
510(K)Number |
K091980
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Product Classification |
Instrument, coagulation, automated - Product Code GKP
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Product |
Instrumentation Laboratory ACL TOP 700 PN 0000280010
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: 09080100 through12060403 Distributed between: Aug 2009 to Jun 2012 |
Recalling Firm/ Manufacturer |
Instrumentation Laboratory Co. 180 Hartwell Road Bedford MA 01730-2443
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For Additional Information Contact |
Same 781-861-4467
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Manufacturer Reason for Recall |
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
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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 |
304 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
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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.
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510(K) Database |
510(K)s with Product Code = GKP and Original Applicant = INSTRUMENTATION LABORATORY CO.
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