FDA-Device2013-05-22Class II
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.
Iris Diagnostics
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.
Sold states
Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
Affected count
942 boxes
Manufactured in
9172 Eton Ave, Chatsworth, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2013Don't want to check this manually?
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