Siemens N Latex HCY Reagent Recalled for Stability Issues
Siemens Healthcare Diagnostics is recalling N Latex HCY Reagent kits due to reduced stability that may cause inaccurate homocysteine test results.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving product performance issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling N Latex HCY REAGENT, REF/Catalog OPAX03, lot 802907632. The product is an in-vitro diagnostic reagent used for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma, and EDTA plasma. The recall involves 62 kits in the United States and 290 kits distributed internationally.
The firm confirmed a reduced once-opened and on-board stability for the affected lot. This stability issue may result in erroneously reduced or elevated homocysteine values, leading to higher than expected lot-to-lot variation and impaired product performance. The device is used to assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The affected product was distributed nationwide in the United States, specifically in the state of Colorado, and to various foreign countries including Austria, Brazil, and Germany. Users should stop using the affected lot and contact Siemens Healthcare Diagnostics for instructions on returning the product.
The recalled product
- Product
- N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 802907632
- Exp. 2017-02-13
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 · 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