Agency classClass IIOur severity:High FDA (Devices)·Z-2494-2020·Announced 2020-07-15

Radiometer ABL800 FLEX Blood Gas Analyzer Software Recall

Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that may cause patient mix-ups.

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 and involves a risk-of-harm product (patient mix-up) where specific injuries or illnesses have not yet been reported in the source text, fitting the 'High' severity criteria.

Plain-English summary

Radiometer Medical ApS is recalling the ABL800 FLEX blood gas and pH test system, Model 393-801, due to a software issue. The recall affects units running software versions 6.19 and below. The issue presents a potential risk of patient mix-up on the analyzers.

The recall covers 3,899 units distributed across 48 U.S. states and the District of Columbia, as well as 27 countries internationally. The affected product is a medical device used for testing blood gases (PCO2, PO2) and blood pH.

Healthcare facilities and users should contact Radiometer Medical ApS for instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.
Manufacturer: Radiometer Medical ApS
Category: Medical Device — Laboratory Equipment
Hazard: patient-mix-up
software-defect
Affected units: 3,899

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 →

Same manufacturer · Radiometer Medical ApS

See all →

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Radiometer AQURE Software Recall Due to Patient Mix-up Risk
FDA (Devices) · 2023-04-26
High
ABL800 Flex Analyzer Recalled for Potential Measurement Bias
FDA (Devices) · 2022-07-13
High
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FDA (Devices) · 2022-05-25

Same hazard · patient mix up