Z-1328-2013 Class II Terminated
FDA device recall Z-1328-2013 was initiated by Iris Diagnostics on September 18, 2012 and is designated Class II. 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 … The recall status is terminated (terminated January 27, 2014). Affected quantity: 942 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- September 18, 2012
- Termination Date
- January 27, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 942 boxes
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
Code Information
Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013