FDA Device Recall Z-0136-2011: Instrumentation Laboratory Co.

Recall Res Number

Z-0136-2011

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2010-08-13

Date Posted

2010-10-25

Date Terminated

2012-05-23

Product Code

GKP

Event Number

56657

Product Quantity

285 units

Product Description ACL TOP 500 CTS PN 000280040 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 Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves

Action Details Instrumentaion Laboratory notified the US Distributor/Canada via BCI Service Modification Notice (#10793) on August 13, 2010. The Mandatory software upgrade to Verison V4.3.0 in the United States and Canada will be conducted by BCI service representatives and tracked through the distributor, Beckman Coulter (BCI). International Affiliates/Dealers: Worldwide Regulatory Notices were e-mailed to IL international affiliates and dealers, notifying them of the mandatory software upgrade, providing issue description and a risk summary and the support. The upgrades were to be handled through the local representatives.

Distribution Pattern Worldwide Distribution, USA and Canada

Code Information / Serial Numbers Serial Number range: 08010100-10061231

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-0136-2011

Recall Parameters & Description

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