Sentinel Ammonia Reagent Recalled for Inaccurate Results in Heparin Tubes
Sentinel CH SpA is recalling 765 kits of Sentinel MULTIGENT Ammonia Ultra Reagent because results may be below the linear range for samples collected in heparin tubes.
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, and the hazard involves potential diagnostic inaccuracy rather than direct physical injury or reported illness, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Sentinel CH SpA is recalling 765 kits of Sentinel MULTIGENT Ammonia Ultra Reagent, an in-vitro diagnostic intended for the quantitative determination of ammonia in human plasma. The recall involves Lot 50083Y600 with an expiration date of July 31, 2016, which was distributed nationwide.
The recall was initiated because ammonia test results are below the linear range of the assay for samples collected in sodium or lithium heparin tubes. This issue may lead to inaccurate measurement of ammonia levels in affected samples.
Healthcare facilities and laboratories that have received this product should stop using the affected kits and contact Sentinel CH SpA for instructions on return or replacement.
The recalled product
- Product
- Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
- Manufacturer
- Sentinel CH SpA
- Hazard
- Affected units
- 765
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 50083Y600
- expiration date 31 Jul 2016.
Distribution
Distributed nationwide across the United States.
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