Iris Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-1328-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 18, 2012

Date Posted: May 22, 2013

Recall Number: Z-1328-2013

Event ID: 64910

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.

Status: Terminated

Product Quantity: 942 boxes

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.

Voluntary or Mandated:

Voluntary: Firm initiated