Hemochron Jr. Whole Blood Microcoagulation system Low Range… recallZ-1381-05 · International Technidyne Corp. · initiated Apr 27, 2005
Terminated All recalls posted in August 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from International Technidyne Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
Recall letter was sent out on 4/27/2005 via First Class Mail.
Recall details
- Recall number
- Z-1381-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 27, 2005
- Posted by the FDA
- Aug 23, 2005
- Recalling firm
- International Technidyne Corp.
- Quantity
- 924 boxes x 45 cuvettes per box
- Product code
- JBP
- FDA submissions
- K960749
- 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.
Product description
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.
Code information (models, lots, serial 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.
Other devices under the same FDA submission
1 device cleared under K960749 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Hemochron Whole Blood Microcoagulation System JACT-LRAccriva Diagnostics Holdings, Inc. · Activated Whole Blood Clotting Time1 recall1 death2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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