Siemens Dimension ALTI Assay Recalled for Drug Interference
Siemens is recalling Dimension ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
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 risk-of-harm product where inaccurate diagnostic results could lead to improper medical decisions, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Alanine Aminotransferase (ALTI) assay, Product Number DF143/10475530. The recall involves 276,511 units distributed in all 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and 108 foreign countries.
The recall was initiated because the assay may interfere with the drugs sulfasalazine and/or sulfapyridine. This interference can cause falsely elevated or falsely depressed results when measuring chemical levels in blood, urine, or cerebrospinal fluid.
Healthcare facilities and laboratories should stop using the affected assays and contact Siemens for further instructions. Patients who have had recent ALTI tests while taking sulfasalazine or sulfapyridine should consult their healthcare provider to discuss the potential impact on their results.
The recalled product
- Product
- Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 276,511
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 (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 17 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 17 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 · drug interference
See all →- HighRAPIDPOINT 500 Blood Gas System: Drug Interference May Cause False Sodium Readings
FDA (Devices) · 2023-12-06
- HighRAPIDPOINT 500e Blood Gas System Recalled Due to Drug Interference
FDA (Devices) · 2023-12-06
- HighMedtronic Enlite Glucose Sensor Recall Due to Hydroxyurea Interference
FDA (Devices) · 2021-05-26
- ModerateOrtho VITROS Chemistry TP Slides Recalled for Eltrombopag Interference
FDA (Devices) · 2021-01-20
- HighOrtho-Clinical Diagnostics Recalls VITROS TBIL Slides Due to Etrombopag Interference
FDA (Devices) · 2020-09-02