Device product
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Z-2088-2014
Product summary
- Firm
- ITC-Nexus Dx
- Event
- Event 68659
- Status
- Terminated
- Classification
- Class II
- Quantity
- US- 315 cuvettes; OUS - 2835 cuvettes
- Official record key
device-enforcement:Z-2088-2014
Official wording
Reason: Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Code information: Lot Number A4JCA001
Distribution pattern: Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
Derived failure modes
-
Unknown
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.