Sekisui Diagnostics Recalls Acetaminophen Assay Kits Due to Crystal Formation
Sekisui Diagnostics is recalling 14,407 Acetaminophen L3K Assay kits because crystal formation in the reagent can cause samples to under-recover.
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. The hazard involves potential inaccuracy in diagnostic results due to crystal formation, which is a significant quality issue but does not involve direct physical injury or death.
Plain-English summary
Sekisui Diagnostics P.E.I. Inc. is recalling 14,407 kits of the Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay. This in-vitro diagnostic is used for the quantitative measurement of acetaminophen in serum and plasma to aid in the diagnosis and treatment of acetaminophen overdose toxicity.
The recall is due to crystal formation in the Color Reagent (R2) when the product is left on board automated analyzers. This condition causes samples to under-recover, which may affect the accuracy of the test results.
The affected products are Catalog Numbers 506-10 and 506-30. Specific lot codes for Catalog Number 506-10 are 47677, 47694, 47649, 47650, 47662, 47663, 48253, 48385, and 48386. Specific lot codes for Catalog Number 506-30 are 47695 and 48294. The products were distributed worldwide, including in the US states of AZ, CA, FL, IA, ID, IL, MA, MN, MT, and ND, as well as in Canada, France, and Hong Kong. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the…
- Manufacturer
- Sekisui Diagnostics P.E.I. Inc.
- Affected units
- 14,407
Distribution
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