Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Recall
- Recall Number
- Z-2088-2014
- Event Number
- 68659
- Firm
- ITC-Nexus Dx
- FEI Number
- 2250033
- Product Code
- JPA
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- June 20, 2014
- Posted
- July 21, 2014
- Terminated
- December 11, 2014
- Address
- 23 Nevsky St, Edison, NJ, 08820-2425
Description
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
ITC issued an Urgent Medical Device Recall Letters/Response Forms dated June 20, 2014, to End-users and US Distributors were notified. ITC asks that this communication be forwarded to all those within your organization who need to be aware of this matter. If any affected products have been forwarded to another facility, a copy of this communication should be forwarded to them immediately. Customers should check their inventory for the affected lot. The affected lot should not be used and quarantined until return to ITC. The attached form should be completed and returned to ITC within 10 days. ITC will review the form and contact the customer to coordinate any returns. For questions, please contact Technical Support: Telephone 732-548-5700, Extension 4011 E-mail: [email protected] Normal business hours are Monday through Friday, 8:00 AM to 6:30 PM, Eastern Time.For urgent matters, Technical Support is available 24 hours per day, 7 days a week.
Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
US- 315 cuvettes; OUS - 2835 cuvettes