Recall Z-2088-2014 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
ITC-Nexus Dx
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
| Date | Jul 21, 2014 (initiated Jun 20, 2014) |
| Status | Terminated |
| Reason | Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples. |
| Root cause | Device Design |
| Action | 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 day |
| Quantity | US- 315 cuvettes; OUS - 2835 cuvettes |
| Distribution | Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940401 | JR. MICROCOAGULATION SYSTEM International Technidyne Corp., May 11, 1994 |