Recall Z-1732-2009
International Technidyne Corp. · initiated May 5, 2009
Product
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.
Codes / lots: Lot number K8JLR118.
Reason for recall
One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
FDA-determined cause: Employee error
Action taken
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 JACTLR@itcmed.com.
Details
- Recall number
- Z-1732-2009
- Initiated
- May 5, 2009
- Posted by FDA
- August 21, 2009
- Terminated
- September 30, 2009
- Product code
- JBP – Activated Whole Blood Clotting Time
- Quantity
- 173 boxes of 45 cuvettes
- Distribution
- Nationwide.
- Recalling firm
- International Technidyne Corp., Edison, NJ