FDAFDA · Food and drugs·Recall number Z-0732-2014
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Published January 22, 2014 · Recall initiated: August 29, 2013
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
High positive calcium bias on plasma sample versus results on serum
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vital Diagnostics, Inc.
- Distributor
- Nationwide Distribution
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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