Device product
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Z-0732-2014
Product summary
- Event
- Event 66202
- Status
- Terminated
- Classification
- Class II
- Quantity
- 395 units
- Official record key
device-enforcement:Z-0732-2014
Official wording
Reason: High positive calcium bias on plasma sample versus results on serum
Code information: All lots
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
High positive calcium bias on plasma sample versus results on serum