Device 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.
Z-1328-2013
Product summary
- Firm
- Iris Diagnostics
- Event
- Event 64910
- Status
- Terminated
- Classification
- Class II
- Quantity
- 942 boxes
- Official record key
device-enforcement:Z-1328-2013
Official wording
Reason: 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.
Code information: Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013
Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
Derived failure modes
-
Unknown
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.