Home / Recalls / Iris Diagnostics / Z-1328-2013

Z-1328-2013 Class II Terminated

Recalled by Iris Diagnostics — Chatsworth, CA

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