FDAFDA · Food and drugs·Recall number Z-2088-2014
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Published July 30, 2014 · Recall initiated: June 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ITC-Nexus Dx
- Distributor
- Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
- Lot
- Lot Number A4JCA001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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