Siemens Dimension Vista MULTI 1 SDIL Diluent Recall for Defective Septum
Siemens is recalling 197 units of Dimension Vista MULTI 1 SDIL diluent due to a potential defect in the vial cap septum that may cause inaccurate test results.
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: The recall involves a medical device defect that can lead to erroneous test results, which is a risk-of-harm scenario where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 197 units of Dimension Vista MULTI 1 SDIL diluent (KD693, SMN# 10469971, Lot # 7BDA81). The recall was initiated because the diluent vial caps may have an incomplete slit on the septum.
This defect has the potential to cause erroneously elevated test results if a sample is autodiluted onboard the system. The issue occurs because a defective septum may result in a reduced volume of diluent being pipetted from the vial.
The affected products were distributed to all 50 US states, DC, Guam, Saipan, and the Virgin Islands, as well as to numerous international locations including Australia, Canada, and various European and Asian countries. Users should stop using the affected diluent and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 197
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 (2)
- lot # 7BDA81
- UDI # (UDI) 008427680303147BDA8118030110469971
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- 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
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06