The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0339-2016·Announced 2015-12-02

Siemens Dimension Vista Magnesium Reagent Cartridge Recall for Low Results

Siemens Healthcare Diagnostics is recalling 3,601 Dimension Vista magnesium reagent cartridges due to erroneous low results that may affect patient and quality control testing.

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 3/5 (High).

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 the hazard involves a risk of harm (erroneous low magnesium results) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 3,601 units of the Dimension Vista System (MG) Flex reagent cartridge, Catalog number K3057, SMN 10445158, Lot Number 15063BA. The product is used for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System.

The recall was initiated because of erroneous low results on a small number of reagent wells. This issue creates the potential for under-recovery in both quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L], which is equivalent to a maximum negative bias of -88%.

The affected products were distributed nationwide in the United States, including DC and specific states, as well as in Canada. No specific instructions for consumers are provided in the source text, but the recall is managed by the recalling firm, Siemens Healthcare Diagnostics, Inc.

The recalled product

Product
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
3,601

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)

  • Lot Number 15063BA

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

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