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 reduces the standard curve slope.
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 source text describes a performance defect (lower absorbance values) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Sekisui Diagnostics LLC is recalling 63 kits of the Spectrolyse PAI-1 In-Vitro Diagnostic Use assay, Catalog # 101201. The product is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The recall covers Lot # 120827, which has an expiration date of 11/27/2012.
The recall was initiated because the assay produces lower than expected absorbance values of 0 IU/ml standard. This issue reduces the slope of the standard curve, which requires more frequent sample dilutions. The agency classification for this recall is Class II.
The affected kits were distributed nationwide, including the states of Florida, Indiana, North Carolina, Ohio, Utah, and Washington. Users of the product should stop using the affected kits and contact Sekisui Diagnostics for further instructions.
The recalled product
- Product
- Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor…
- Manufacturer
- Sekisui Diagnostics Llc
- Hazard
- Affected units
- 63
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 # 120827
- exp 11/27/2012
Distribution
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