CLASS II Device recall · Reported 22 Jan 2014 · FDA Enforcement Report
Envoy Calcium Reagent For In-Vitro Diagnostic Use recalled
Vital Diagnostics is recalling Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use, distributed nationwide in the US. The recall was initiated on 29 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0732-2014
- FDA event ID
- 66202
- Recalling firm
- Vital Diagnostics, Lincoln, RI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Aug 2013
- FDA classified
- 14 Jan 2014
- Reported
- 22 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Aug 2013 | Recall initiated by company | |
| 14 Jan 2014 | Classified by FDA | +138 days |
| 22 Jan 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
High positive calcium bias on plasma sample versus results on serum
Product as listed by the FDA
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Envoy Calcium Reagent For In-Vitro Diagnostic Use recalled?
Yes. Vital Diagnostics recalled Envoy Calcium Reagent For In-Vitro Diagnostic Use on 29 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-0732-2014.
Why was it recalled?
High positive calcium bias on plasma sample versus results on serum
Which lots are affected?
All lots
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vital Diagnostics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro recalled | Vital Diagnostics | Other | Nationwide |
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