Sekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values
Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which may require more frequent sample dilutions.
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 a performance defect (lower absorbance) that affects test accuracy but does not present an immediate physical safety risk like injury or death.
Plain-English summary
Sekisui Diagnostics LLC is recalling 699 kits of the Spectrolyse PAI-1 in-vitro diagnostic assay. The product is used for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The affected lots are 120425 and 120601, and the kits were distributed nationwide in the United States, including Florida, Indiana, Illinois, and Washington.
The recall was initiated because the assay produces lower than expected absorbance values with the "0" standard. This issue reduces the slope of the standard curve, which requires the user to make more frequent sample dilutions to perform the test correctly.
Healthcare facilities and laboratories that have purchased these kits should stop using the affected lots and contact Sekisui Diagnostics for further instructions on returns or replacements.
The recalled product
- Product
- Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human…
- Manufacturer
- Sekisui Diagnostics Llc
- Hazard
- Affected units
- 699
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 (1)
- Lot Numbers: 120425 and 120601
Distribution
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