Iris Diagnostics Recalls iQ Control/Focus Sets Due to Performance Issues
Iris Diagnostics is recalling iQ Control/Focus Sets because customer complaints indicated the product failed to meet performance specifications, preventing patient sample testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a performance defect that prevents testing, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Iris Diagnostics is recalling 942 boxes of the iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. This product is intended for in vitro diagnostic use with the iQ200 series. The affected units were distributed worldwide, including in the United States, Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, the United Kingdom, Germany, and Paraguay.
The recall was initiated following customer complaints that the product's recovery compared to assigned assay values was significantly below specification. This performance issue resulted in the instrument not passing controls, which prevented customers from running patient samples.
The agency has classified this recall as Class II. Users of the affected product should stop using the iQ Control/Focus Set and contact Iris Diagnostics for further instructions.
The recalled product
- 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
- Iris Diagnostics
- Hazard
- Affected units
- 942
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013
Distribution
Distributed nationwide across the United States.
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