International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems.
FDA Recall Z-2200-2010 · Posted 2010-08-10
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Recalling FirmInternational Technidyne Corp.
Recall StatusTerminated
Product CodeGGN
Date Initiated2010-06-25
Date Terminated2010-09-23
Product Quantity122 boxes in US, 1 out of US.
Reason for Recall
The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes
Firm Action
ITC sent Urgent Medical Device Correction letters on June 25, 2010 by Federal Express to hospital Risk Managers and Lab Directors, Clinical Laboratory Manager or Point-of-Care Coordinators.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide and one customer in Belgium.
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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