ACL 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.
FDA Recall Z-0138-2011 · Posted 2010-10-25
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Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeGKP
Date Initiated2010-08-13
Date Terminated2012-05-23
Product Quantity609 units
Reason for Recall
Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution, USA and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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