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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
International Technidyne Corp.
Lot Codes / Batch Numbers
Catalog No. JACT-LR Lot No''s: M4JLR164, Exp. 3/2006, M4JLR165, Exp. 3/2006, A5JLR001, Exp. 4/2006, A5JLR002, Exp. 4/2006, A5JLR003, Exp. 4/2006, C5JLR032, Exp. 6/2006.
Products Sold
Catalog No. JACT-LR Lot No''s: M4JLR164, Exp. 3/2006; M4JLR165, Exp. 3/2006; A5JLR001, Exp. 4/2006; A5JLR002, Exp. 4/2006; A5JLR003, Exp. 4/2006; C5JLR032, Exp. 6/2006.
International Technidyne Corp. is recalling Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvette due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Recall letter was sent out on 4/27/2005 via First Class Mail.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026