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Iris Diagnostics recalls Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro
Recalled May 22, 2013 · FDA recall Z-1328-2013 · 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. · FDA Class II
Units
942 boxes
Sold at
Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
Description
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.
Product
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.
Manufacturer(s)
Iris Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →