Instrumentation Laboratory Co.: Medical Device Recall in 2012 - (Recall #: Z-2391-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 3, 2012

Date Posted: September 26, 2012

Recall Number: Z-2391-2012

Event ID: 62894

Reason for Recall:

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

Status: Terminated

Product Quantity: 2171 units

Code Information:

Serial Number range: 08010100 through 12062270 Distributed between: Jan 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.

Voluntary or Mandated:

Voluntary: Firm initiated