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Recall Observatory FDA recall evidence

Device product

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

Z-2390-2012

August 03, 2012

Class II

Product summary

Firm
Instrumentation Laboratory Co.
Event
Event 62894
Status
Terminated
Classification
Class II
Quantity
46 units
Official record key
device-enforcement:Z-2390-2012

Official wording

Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Code information: Serial Number range: 08120100 through 12060145 Distributed between: Dec 2008 to Jun 2012

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low