Recall Z-0732-2014— Vital Diagnostics, Inc.

Name: FDA recall Z-0732-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-29

Class II · Terminated

Class II FDA medical device recall by Vital Diagnostics, Inc., initiated 2013-08-29, terminated 2015-08-26. It names one FDA 510(k) clearance: K120626. Product: Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum. Reason: High positive calcium bias on plasma sample versus results on serum.

Recalling firm: Vital Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Terminated: 2015-08-26
Firm location: Lincoln, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K120626 — EON CALCIUM REGENTVital Diagnostics (Manufacturing) Ptyltd·cleared 2012-08-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.