FDAClass IIJanuary 22, 2014

Vital Diagnostics Envoy Calcium Reagent For In-Vitro recall

Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum

Why was Vital Diagnostics Envoy Calcium Reagent For In-Vitro recalled?

High positive calcium bias on plasma sample versus results on serum

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots

Product
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Recalling firm
Vital Diagnostics, Inc.
Quantity
395 units
Distribution
Nationwide Distribution
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls