The Recall Desk
HighFDA (Devices)·Z-2493-2020·Announced 2020-07-15

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.

What this means for you

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 ABL800Bas
Manufacturer
Radiometer Medical ApS
Category
Medical Device — Blood Gas Analyzer
Hazard
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

Distributed in 46 states:

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

Same manufacturer · Radiometer Medical ApS

See all →

Same hazard · patient mix up

See all →