FDA Device recall Z-0732-2014
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use by Vital Diagnostics, citing high positive calcium bias on plasma sample versus results on serum.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0732-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-29 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Vital Diagnostics |
| Distribution | US |
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
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0732-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.