Radiometer America Inc: Medical Device Recall in 2014 - (Recall #: Z-2597-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.

Product Classification:

Class II

Date Initiated: July 28, 2014

Date Posted: September 17, 2014

Recall Number: Z-2597-2014

Event ID: 68982

Reason for Recall:

Status: Terminated

Product Quantity: N/A

Code Information:

Verions 2.4X, 2.5X and 2.6X

Distribution Pattern:

Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated