The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0732-2014·Announced 2014-01-22

Vital Diagnostics Envoy Calcium Reagent Recalled for High Positive Bias

Vital Diagnostics is recalling Envoy Calcium Reagent (PN 55285) due to high positive calcium bias in plasma samples compared to serum results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for a diagnostic reagent with a performance issue (bias) that could lead to incorrect test results, but no direct patient injury or illness is reported in the source text.

Plain-English summary

Vital Diagnostics, Inc. is recalling 395 units of Envoy Calcium Reagent for In-Vitro Diagnostic Use (PN 55285). The product is used for the quantitative measurement of calcium in plasma and serum. The recall was initiated because of a high positive calcium bias observed on plasma samples when compared to results on serum.

The recalled product was distributed nationwide. All lots are affected by this recall. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare facilities and laboratories should stop using the affected product and contact Vital Diagnostics, Inc. for instructions on return or replacement. Consumers are not directly affected as this is an in-vitro diagnostic product used in professional settings.

The recalled product

Product
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Manufacturer
Vital Diagnostics, Inc.
Category
Medical Device — In-Vitro Diagnostic Reagent
Hazard
Affected units
395

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Vital Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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