Sekisui Diagnostics Ammonia L3K Assay Recalled for Performance Issues
Sekisui Diagnostics is recalling specific lots of the Ammonia L3K Assay because atypical optical density decreases may impact performance at the high end of the linear range.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific hazard is a performance issue (atypical OD decrease) rather than a direct physical injury or contamination, fitting the Moderate category for a medical device with potential impact on test accuracy.
Plain-English summary
Sekisui Diagnostics P.E.I. Inc. is recalling certain lots of the Ammonia L3K Assay, used for the in vitro quantitative measurement of ammonia concentration in plasma. The recall involves 774 liters of bulk product and 565 kits.
The recall is being conducted because certain lots are showing an atypical decrease in optical density (OD) over time. This issue may result in an impact to performance at the high end of the linear range.
The affected products were distributed worldwide, including in the United States and internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, and Sri Lanka. Healthcare facilities and laboratories should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
- Manufacturer
- Sekisui Diagnostics P.E.I. Inc.
- Hazard
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 (10)
- Catalog Number: 293-80-91
- Lot Numbers: 48737
- 48962
- 49087
- 49220
- 49258 and Catalog Numbers: 293-10
- Lot Numbers: 48967
- 49330
- 49331
- 49515
Distribution
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