Siemens Vista Drug 4 Calibrator Recalled for Low Bias
Siemens is recalling Vista Drug 4 Calibrators because they cause low digoxin test results, potentially affecting patient care.
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: The recall involves a medical device that produces inaccurate diagnostic results (15% low bias), which poses a risk of harm to patients through incorrect treatment decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,638 units of the Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The recall involves specific lots of the calibrator used for in vitro diagnostic testing.
The recall was initiated after Siemens confirmed complaints of low quality control and patient recovery results when using the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge. Internal testing indicated an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL when calibrating with the affected lots.
The affected products were distributed to laboratories in 44 states, the District of Columbia, and Puerto Rico. Users should stop using the affected calibrators and contact Siemens for instructions on returning the product.
The recalled product
- Product
- Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,638
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 (7)
- Catalog Number KC460
- SMN 10472284
- lot 2KD052
- exp 5/1/14 and Catalog Number KC460A
- SMN 10476471
- lot 2KD053
- exp 5/1/14.
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 · inaccurate diagnostic results
See all →- Highi-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results
FDA (Devices) · 2026-05-06
- HighSiemens epoc BGEM Test Card Recalled for Inconsistent Glucose Results
FDA (Devices) · 2020-09-23
- ModerateTosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues
FDA (Devices) · 2020-09-23
- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighSiemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift
FDA (Devices) · 2020-02-26
Similar recalls
- ModerateSiemens Recalls Dimension Vista Myoglobin Calibrator Due to Positive Result Shift
FDA (Devices) · 2015-01-14
- ModerateSiemens Dimension Vista Systems Recalled for Software Processing Errors
FDA (Devices) · 2015-07-15
- ModerateSiemens Dimension Vista Protein 1 Calibrator Recalled for Inaccurate Ceruloplasmin Results
FDA (Devices) · 2017-12-06
- LowSiemens Recalls Dimension Vista Vancomycin Reagent Cartridges
FDA (Devices) · 2012-08-15
- HighSiemens Dimension Vista Chemistry 1 Calibrator Recall for Low Calcium Recovery
FDA (Devices) · 2016-11-30
- HighSiemens Dimension Vista LOCI 8 Calibrator Recalled for Calibration Failures
FDA (Devices) · 2018-04-04