Vital Diagnostics Recalls Eon Calcium Reagent Due to High Positive Bias
Vital Diagnostics, Inc. is recalling 213 units of Eon Calcium Reagent because high positive calcium bias was observed in plasma samples compared to serum results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a diagnostic accuracy issue (high positive bias) that could lead to incorrect clinical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vital Diagnostics, Inc. is recalling 213 units of Consult Diagnostics Eon Calcium Reagent (PN: 1429) for in-vitro diagnostic use. The product is used for the quantitative measurement of calcium in plasma and serum. The recall was initiated because high positive calcium bias was observed on plasma samples versus results on serum.
The recall covers all lots of the product, which was distributed nationwide. The agency has classified this as a Class II recall. No specific dates, lot numbers, or illness counts are provided in the source text.
Consumers and healthcare facilities should stop using the affected reagent and contact Vital Diagnostics, Inc. for instructions on return or replacement.
The recalled product
- Product
- Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
- Manufacturer
- Vital Diagnostics, Inc.
- Hazard
- Affected units
- 213
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 →Related recalls
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