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.
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: 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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
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