FDAFDA · Food and drugs·Recall number Z-1720-2016
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Published June 1, 2016 · Recall initiated: April 22, 2016
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
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Accriva Diagnostics Inc., dba ITC, dba Accumetrics
- Distributor
- U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.
- Lot
- Lot #B6JCA012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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