FDAFDA · Food and drugs·Recall number Z-1328-2013
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.
Published May 22, 2013 · Recall initiated: September 18, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Iris Diagnostics
- Distributor
- Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
- Lot
- Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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