FDA-Device2014-01-22Class II

Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum

Vital Diagnostics, Inc.
Hazard

High positive calcium bias on plasma sample versus results on serum

Sold states
Nationwide Distribution
Affected count
213 units
Manufactured in
27 Wellington Rd, Lincoln, RI, United States
Products
Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0733-2014

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