Recall Z-1381-05 ยท JBP Activated Whole Blood Clotting Time
International Technidyne Corp.
Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820.
| Date | Aug 23, 2005 (initiated Apr 27, 2005) |
| Status | Terminated |
| Reason | Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media. |
| Root cause | Other |
| Action | Recall letter was sent out on 4/27/2005 via First Class Mail. |
| Quantity | 924 boxes x 45 cuvettes per box |
| Distribution | Products were distributed domestically to customers nationwide. Products were also distributed internationally to customers in the following countries: Italy, Sweden, Norway, Germany, and Japan. Products were distributed to the VA Medical Center, Los Angeles, CA 90073. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT International Technidyne Corp., Aug 12, 1996 |