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
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.
These labels are deterministic app interpretations, not FDA categories.
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.
Code information
Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013
Distribution pattern
Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
