Z-2088-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2014
- Initiation Date
- June 20, 2014
- Termination Date
- December 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US- 315 cuvettes; OUS - 2835 cuvettes
Product Description
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Reason for Recall
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Distribution Pattern
Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
Code Information
Lot Number A4JCA001