Siemens Recalls Dimension Vista Vancomycin Reagent Cartridges
Siemens is recalling Dimension Vista Vancomycin Reagent Cartridges because calibration failures prevent the vancomycin assay from running.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a functional failure preventing the test from running, with no reported injuries or illnesses.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,894 cartons of Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridges (Catalog # K4086). The affected product is lot 12095AD, with an expiration date of April 4, 2013. This product is used for the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
The recall was initiated after Siemens received complaints from customers experiencing calibration slopes greater than 1.05. This issue results in a slope failure, which prevents the vancomycin assay from being run on the Dimension Vista system.
The affected cartridges were distributed worldwide, including in the United States, Canada, New Zealand, Germany, and Puerto Rico. Users of the Dimension Vista system should check their inventory for lot 12095AD and stop using these cartridges if found.
The recalled product
- Product
- Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,894
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 12095AD
- exp 2013-04-04
Distribution
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 · functional failure
See all →- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighSoftware Malfunction Disables Back Control on Baxter TruSystem 7500
FDA (Devices) · 2025-04-02
- HighBaxter TruSystem 7500 Hybrid software issue disables upper back adjustment
FDA (Devices) · 2025-04-02
- SevereCardiac catheters recalled due to polyurethane layer delamination defects
FDA (Devices) · 2024-05-22
- HighBard PreVent Anti-Reflux Filter with ENFit Recall for Reduced Suction
FDA (Devices) · 2024-01-31