Recall Z-1732-2009 ยท JBP Activated Whole Blood Clotting Time
International Technidyne Corp.
Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems; International Technidyne Corp., Edison, NJ 08820. The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effe
| Date | Aug 21, 2009 (initiated May 5, 2009) |
| Status | Terminated |
| Reason | One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria. |
| Root cause | Employee error |
| Action | An "Urgent - Medical Device Recall" letter dated May 4, 2009 was sent to healthcare professionals. The recall letter described the reason for recall and the possible health risks involved. Consignees were asked to check their inventory for the affected lot number and return the completed Customer Account Tracking form via mail, e-mail or fax to ITC. ITC will make arrangements for the return of affected product. If there is no affected product in the inventory and no product or safety concerns, the letter is for information purposed only. Note: the Customer Account Tracking form should be |
| Quantity | 173 boxes of 45 cuvettes |
| Distribution | Nationwide. |
| 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 |