openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
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 plasma. The test is for in Citro diagnostic use.
SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
These labels are deterministic app interpretations, not FDA categories.
SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
Code information
Lot Numbers: 120425 and 120601
Distribution pattern
Nationwide distribution: USA including states of: FL, IN, IL, and WA.
