Recall Z-1093-2011 ยท KQG Instrument, Coagulation
International Technidyne Corp.
Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), intervention
| Date | Feb 11, 2011 (initiated Nov 30, 2010) |
| Status | Terminated |
| Reason | Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot. |
| Root cause | Process control |
| Action | ITC notified their distributors and end user customers with an Urgent Medical Device Recall letter dated November 29, 2010 through UPS overnight mail. The letter identified the affected product and explained the reason for the recall. Distributors and customers should check their inventory for any affected product. Distributors should immediately discontinue shipment of the affected product and place the product on hold. Then regardless of whether they have any remaining inventory, they should complete the enclosed Distributor Account Tracking Form. The firm will contact them to arrange f |
| Quantity | 265 boxes (95 ACT Tubes per box) |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983475 | HEMOCHRON RESPONSE International Technidyne Corp., May 3, 1999 |