Recall Z-1786-2010 ยท GGN Plasma, Coagulation Control
International Technidyne Corporation
directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.
| Date | Jun 11, 2010 (initiated Apr 15, 2010) |
| Status | Terminated |
| Reason | Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect. |
| Root cause | Error in labeling |
| Action | Notification letters were sent vis Federal Express on April 15, 2010 to all distributors and end users to return unused product or to replace the package insert. Please direct questions ITC Technical Support at phone 800-631-5945 Ext. 4707. |
| Quantity | 94 boxes |
| Distribution | Distributors and medical facilities in AZ, CA, IL, KY, MA, MD, ME, MO, PA, WA. Foreign distribution to Australia, Canada, Switzerland, Germany, Spain, Quatar, and Saudi Arabia. |
| 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 |