FDA Device Recall Z-2391-2012: Instrumentation Laboratory Co.

Recall Res Number

Z-2391-2012

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-08-03

Date Posted

2012-09-14

Date Terminated

2015-10-02

Product Code

GKP

Event Number

62894

Product Quantity

2171 units

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

Reason for Recall Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Action Details 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.

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.

Code Information / Serial Numbers Serial Number range: 08010100 through 12062270 Distributed between: Jan 2008 to Jun 2012

Fisher Diagnostics Registration: 1181121 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
HELENA LABORATORIES, CORP. Registration: 1644474 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SYSMEX CORPORATION KAKOGAWA FACTORY Registration: 3002759288 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Sysmex America, Inc. Registration: 3009711478 View Registration
Sysmex RA Co., LTD, Main Office Registration: 3010188766 View Registration
BEMOTEC GMBH Registration: 3010362364 View Registration
SYSMEX CORPORATION Registration: 3010421384 View Registration
SYSMEX CORPORATION i-SQUARE Registration: 3010960914 View Registration
Sysmex America, Inc. - Vernon Hills Registration: 3020704087 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Diagnostica Stago - Gennevilliers Registration: 8043723 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
SYSMEX CORPORATION TECHNO PARK Registration: 9613959 View Registration

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Medical Device Recall: Z-2391-2012

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