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Recall Observatory FDA recall evidence

Device product

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

Z-2389-2012

August 03, 2012

Class II

Product summary

Firm
Instrumentation Laboratory Co.
Event
Event 62894
Status
Terminated
Classification
Class II
Quantity
562 units
Official record key
device-enforcement:Z-2389-2012

Official wording

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

Code information: Serial Number range: 06020101 through 10080662 Distributed between: Feb 2006 to Aug 2010

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