Siemens ALT Assay Reagents Recalled for Drug Interference
Siemens Healthcare Diagnostics is recalling ADVIA ALT reagent chemistry assays because they may produce inaccurate results when used with certain drugs.
What this means for you
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is limited to inaccurate test results due to drug interference, with no reported injuries or deaths.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays. The affected products are intended to measure the activity of the enzyme alanine amino transferase in serum and plasma. The recall includes specific product and part numbers for ALT, ALT P5P, and ALT Concentrated reagents.
The recall is being issued because these assays may interfere with the drugs sulfasalazine and/or sulfapyridine. This interference can cause falsely elevated or falsely depressed test results. The source text does not specify the number of affected units, specific lot numbers, or the date of distribution.
The recalled products were distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico, as well as in 108 foreign countries. Consumers and healthcare providers should stop using these specific reagent products and contact Siemens Healthcare Diagnostics for further instructions or replacements.
The recalled product
- Product
- ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Pa
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 33,233
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 · 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