FDA Recall
Terminated
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.
Recall: Z-2200-2010
·
Initiated June 25, 2010
Recall
- Recall Number
- Z-2200-2010
- Event Number
- 56117
- Firm
- International Technidyne Corp.
- FEI Number
- 1000526865
- Product Code
- GGN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 25, 2010
- Posted
- August 10, 2010
- Terminated
- September 23, 2010
- Address
- 6-8 Olsen Avenue, Edison, NJ, 08820-2419
Description
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.
Reason
The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes
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.
Distribution
Nationwide and one customer in Belgium.
Quantity
122 boxes in US, 1 out of US.