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ITC-Nexus Dx recalls Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog numbe
Recalled July 30, 2014 · FDA recall Z-2088-2014 · ITC-Nexus Dx
Hazard
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples. · FDA Class II
Units
US- 315 cuvettes; OUS - 2835 cuvettes
Sold at
Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
Description
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Product
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Manufacturer(s)
ITC-Nexus Dx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →