Siemens Syva Emit Methotrexate Assay Recalled for Stability Failure
Siemens Healthcare Diagnostics is recalling Syva Emit Methotrexate Assay units because they failed to meet the 20-hour on-board stability claim, potentially causing increased methotrexate 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a stability failure leading to increased test values, which is a significant quality issue but does not involve reported injuries, deaths, or high-risk pathogens, fitting the Moderate criteria for a voluntary precautionary recall of a medical device.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 18,364 units of the Syva Emit Methotrexate Assay (Lot # F1, F2, G1, G2, H1, and H2). This homogeneous enzyme immunoassay is intended for the quantitative analysis of methotrexate in human serum or plasma. The affected units were distributed to various locations in the United States, including MI, FL, NJ, NY, DC, CA, GA, MT, VA, NC, TX, and PA, as well as to Australia, Belgium, the Czech Republic, Finland, Japan, the Republic of Korea, Italy, Saudi Arabia, Slovakia, Slovenia, Spain, and Switzerland.
The recall was initiated because the Syva Emit Methotrexate Application (DVMTX.1) for the Dimension Vista System does not meet the On-Board Stability claim of 20 hours. Testing conducted using the reagent at the end of the 20-hour stability period showed that methotrexate values for patient and quality control samples increased. This deviation from the stated stability claim may affect the accuracy of test results.
The recalled product
- Product
- Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 18,364
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 (6)
- Lot # F1
- F2
- G1
- G2
- H1
- and H2
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · stability failure
See all →- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
Similar recalls
- ModerateSyva EMIT 2000 Theophylline Assay Recalled for Increased Imprecision
FDA (Devices) · 2018-06-06
- ModerateSiemens Syva EMIT 2000 Theophylline Reagent Recall for Imprecision
FDA (Devices) · 2016-08-03
- HighSiemens Syva Emit 2000 Sirolimus Assay Recalled for Interference
FDA (Devices) · 2018-05-16
- ModerateSiemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision
FDA (Devices) · 2013-01-16
- HighSiemens Healthcare Recalls Emit 2000 Phenobarbital Assay Due to Imprecision
FDA (Devices) · 2013-11-13
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12