Home / Recalls / Vital Diagnostics, Inc. / Z-0732-2014

Z-0732-2014 Class II Terminated

Recalled by Vital Diagnostics, Inc. — Lincoln, RI

Recall Details

Product Type: Devices
Report Date: January 22, 2014
Initiation Date: August 29, 2013
Termination Date: August 26, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 395 units

Product Description

Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum

Reason for Recall

High positive calcium bias on plasma sample versus results on serum

Distribution Pattern

Nationwide Distribution

Code Information

All lots