Hemochron Jr. ACT- LR Assay (JACT- LR) recallZ-1732-2009 · International Technidyne Corp. · initiated May 5, 2009
Terminated All recalls posted in August 2009
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
One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
FDA root cause category: Employee error
What the company is doing
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 completed in all cases. If you have questions regarding the recall information, please call ITC Technical Support at 1-800-579-2255, or email ITC at [email protected].
Recall details
- Recall number
- Z-1732-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 5, 2009
- Posted by the FDA
- Aug 21, 2009
- Recalling firm
- International Technidyne Corp.
- Quantity
- 173 boxes of 45 cuvettes
- Product code
- JBP
- FDA submissions
- K960749
- Distribution
- Nationwide.
Product description
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 effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty.
Code information (models, lots, serial numbers)
Lot number K8JLR118.
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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