Z-0733-2014 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
213 units

Product Description

Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 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