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U.S. Department of Health and Human Services

Class 2 Device Recall Instrumentation Laboratory

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 Class 2 Device Recall Instrumentation Laboratorysee related information
Date Initiated by FirmAugust 13, 2010
Date PostedOctober 25, 2010
Recall Status1 Terminated 3 on May 23, 2012
Recall NumberZ-0138-2011
Recall Event ID 56657
510(K)NumberK091980 
Product Classification Instrument, coagulation, automated - Product Code GKP
ProductACL TOP CTS PN 000280020 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.
Code Information Serial Number range: 06020101-10030659
Recalling Firm/
Manufacturer		 Instrumentation Laboratory Co.
180 Hartwell Road
Bedford MA 01730-2443
For Additional Information Contact
781-861-4467
Manufacturer Reason
for Recall		Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
FDA Determined
Cause 2		Software design
ActionInstrumentaion 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.
Quantity in Commerce609 units
DistributionWorldwide Distribution, USA and Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GKP
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