Radiometer ABL800 FLEX Blood Gas Analyzers Recalled for Software Issues
Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that creates a potential risk of patient mix-up.
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 involves a medical device with a potential risk of patient mix-up, which is a risk-of-harm scenario where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Radiometer Medical ApS is recalling 4,615 units of the ABL800 FLEX blood gas and pH test system, Model Number 393-800. The recall covers various configurations of the device, including the ABL835, ABL830, ABL827, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805, and ABL800Basic. The affected units are those running software versions 6.19 and below.
The recall is being conducted because of a software issue that presents a potential risk of patient mix-up on the analyzers. The source text does not specify the exact nature of the software defect or provide details on how the mix-up occurs.
The affected devices were distributed in the United States and internationally, including in Australia, Canada, and various European and Asian countries. The source text does not provide specific instructions for consumers or healthcare providers on how to address the issue, nor does it report any specific injuries or illnesses resulting from the defect.
The recalled product
- Product
- Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and…
- Manufacturer
- Radiometer Medical ApS
- Affected units
- 4,615
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 (1)
- Software versions 6.19 and below.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Radiometer Medical ApS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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