Recall Z-2200-2010 ยท GGN Plasma, Coagulation Control
International Technidyne Corp.
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.
| Date | Aug 10, 2010 (initiated Jun 25, 2010) |
| Status | Terminated |
| Reason | The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 122 boxes in US, 1 out of US. |
| Distribution | Nationwide and one customer in Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II International Technidyne Corp., Mar 15, 1995 |