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.
FDA Recall Z-1328-2013 · Posted 2013-05-15
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Recalling FirmIris Diagnostics
Recall StatusTerminated
Product CodeJJW
Date Initiated2012-09-18
Date Terminated2014-01-27
Product Quantity942 boxes
Reason for Recall
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.
Firm Action
IRIS sent a Medical Device Recall letter dated September 18, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to dispose of all unopened or partially used inventory, complete the attached worksheet certifying the disposal of the affected product and email or fax to Iris Diagnostics.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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