Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use — Class II medical device recall Z-0732-2014
Terminated recall by Vital Diagnostics, Inc., reported 2014-01-22, distributed nationwide. High positive calcium bias on plasma sample versus results on serum
| Recall number | Z-0732-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Diagnostics, Inc., Lincoln, RI, United States |
| Recall initiated | 2013-08-29 |
| Classified | 2014-01-14 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2015-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 395 units |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0732-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.