The Recall Desk
HighFDA (Devices)·Z-0830-2022·Announced 2022-04-06

Siemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors

Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.

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: This is an FDA Class II recall of a diagnostic medical device. Although no illnesses or injuries have been reported, imprecision in magnesium measurement represents a risk-of-harm product where diagnostic errors could lead to inappropriate treatment decisions, meeting the High severity threshold for risk-of-harm products without reported injury.

Plain-English summary

Siemens Healthcare Diagnostics is recalling Dimension Vista Magnesium Flex reagent cartridges (Material #10445158, Catalog #K3057) used in Dimension Vista diagnostic testing systems. These cartridges measure magnesium levels in patient serum, plasma, and urine samples for diagnosis and treatment monitoring.

The recalled cartridges may exhibit imprecision and intermittent abnormal assay flags, which can result in quality control failures or erroneous patient results. Affected lots are 21253BB, 21263BA, and 21335AA. No illnesses or injuries have been reported.

Approximately 14,220 units were distributed worldwide, including 47 U.S. states, Australia, Canada, and the Netherlands. Healthcare facilities using affected cartridge lots should discontinue use and contact Siemens for replacement information.

Patients who may have received testing using affected cartridges should consult their healthcare providers to determine if retesting is needed.

The recalled product

Product
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Diagnostic Reagent / In Vitro Diagnostic Test
Hazard
  • imprecision
  • assay-error
  • diagnostic-error

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 (5)

  • [lot 21253BB
  • UDI: 0084276801569421253BB22091010445158840]
  • [lot 21263BA UDI: 0084276801569421263BA22092010445158840]
  • [lot 21335AA
  • UDI: 0084276801569421335AA22120110445158840]

Distribution

Distributed nationwide across the United States.

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