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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 62894
Product Type Devices
Status Ongoing
Recalling Firm Instrumentation Laboratory Co.
City Bedford
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-03
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 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 Serial Number range:03110101 through 11111174 Distributed from: Nov 2003 to Nov 2011 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 1074 units Z-2387-2012
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 Serial Number range: 09080100 through12060403 Distributed between: Aug 2009 to Jun 2012 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 304 units Z-2388-2012
Instrumentation Laboratory ACL TOP CTS PN 0000280020 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 Serial Number range: 06020101 through 10080662 Distributed between: Feb 2006 to Aug 2010 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 562 units Z-2389-2012
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 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 Serial Number range: 08120100 through 12060145 Distributed between: Dec 2008 to Jun 2012 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 46 units Z-2390-2012
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 Serial Number range: 08010100 through 12062270 Distributed between: Jan 2008 to Jun 2012 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 2171 units Z-2391-2012
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 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 Serial Number range: 09120101 through 12060240 Distributed between: Dec 2009 to Jun 2012 Class II Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 140 units Z-2392-2012
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