Z-2597-2014Class II

RADIANCE v. 2.4X, 2.5X and 2.6X

Name: Z-2597-2014 RADIANCE v. 2.4X, 2.5X and 2.6X
Creator: Radiometer America Inc
Published: 2014-07-28
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2014-07-28 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of 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... on 2014-07-28. FDA classified it as Class II. As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2597-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-28
Posted: 2014-09-06
Terminated: 2014-10-15
Recalling firm: Radiometer America, Inc
Product: 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 code: JQP Calculator/Data Processing Module, For Clinical Use
Root cause tag: software
FDA root cause: Software design
Action: Radiometer sent an Product Notification letter dated July 31, 2014 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. The letter informed customers that local RADIOMETER IT specialist will contact customers in order to schedule the upgrade to v. 2.74 or 3.5.2. All RADIANCE versions below 2.7X will be upgraded to v. 2.74 or 3.5.2. For questions regarding this letter or the Recall, please contact Radiometer America Technical Support at 1-800-736-0600 opt.4.
Quantity in commerce: N/A
Distribution: 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.
Product codes and lots: Verions 2.4X, 2.5X and 2.6X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2597-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2597-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-05

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)