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.
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 2/5 (Moderate).
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…
- 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
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