Radiometer America Recalls RADIANCE Clinical Data Processing Software Versions 2.4X to 2.6X
Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This aligns with the 'High' severity category for risk-of-harm products where specific injury reports are not detailed in the source.
Plain-English summary
Radiometer America Inc. has initiated a voluntary recall of RADIANCE software versions 2.4X, 2.5X, and 2.6X. RADIANCE is a data processing application intended for clinical use to monitor, collect, store, retrieve, and process laboratory data, as well as to control clinical analyzers. The recall was initiated on July 28, 2014, and was classified as Class II by the FDA on September 5, 2014.
The affected software was distributed worldwide, including in the United States (specifically in Arizona, California, Missouri, Mississippi, Texas, and Utah) and in Australia, Austria, France, the UK, Italy, Japan, Spain, India, and the Netherlands. The source text does not specify the exact reason for the recall or the number of units affected.
The recall status is listed as Terminated as of October 15, 2014. The firm notified customers via letter. Users of the affected software versions should consult the manufacturer for specific instructions regarding the recall.
The recalled product
- 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.
- Manufacturer
- Radiometer America Inc
- Category
- Medical Device — Software
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Verions 2.4X
- 2.5X and 2.6X
Distribution
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