Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sekisui Diagnostics Recalled by Sekisui Diagnostics Llc Due to Spectrolyse PAI-1 activity assay, producing lower than expected...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sekisui Diagnostics Llc directly.
Affected Products
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 Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.
Quantity: 63 kits
Why Was This Recalled?
Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sekisui Diagnostics Llc
Sekisui Diagnostics Llc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report