Z-0732-2014 Class II Terminated
FDA device recall Z-0732-2014 was initiated by Vital Diagnostics, Inc. on August 29, 2013 and is designated Class II. Reason for recall: High positive calcium bias on plasma sample versus results on serum The recall status is terminated (terminated August 26, 2015). Affected quantity: 395 units.
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