Siemens Magnesium Test Cartridges May Produce Erroneous Results Without Alert
Siemens Dimension Magnesium Flex reagent cartridges may produce inaccurate test results without triggering warning flags. Some results may show magnesium levels 15–59% lower than actual values.
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: FDA Class II diagnostic device with documented erroneous results not always caught by quality control, posing significant risk to patient care decisions. No injuries or hospitalizations reported, classifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics has recalled Dimension Magnesium (MG) Flex reagent cartridges used in clinical laboratories to measure magnesium levels in patient blood samples. Approximately 26,851 units are affected, distributed nationwide and internationally.
The cartridges may exhibit imprecision that produces erroneous test results. In some cases, the laboratory's quality control system may not detect these errors, allowing incorrect results to be reported without an Abnormal Reaction warning flag. Based on customer data, affected cartridges may report magnesium levels 15% to 59% lower than actual values.
Affected lot numbers are FA2350, FA2356, GA2363, and FA3019. Healthcare facilities should identify and remove these cartridges from use. Patients who received magnesium test results from these lots should consult with their healthcare provider about the need for retesting.
The recalled product
- Product
- Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 26,851
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 (3)
- MG lot FA2356 10444963 00842768014185FA235622122210444963840
- MG lot GA2363 10444963 00842768014185GA236322122910444963840
- MG lot FA3019 10444963 00842768014185FA301923011910444963840
Distribution
Distributed nationwide across the United States.
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