Agency classClass IIOur severity:Severe FDA (Devices)·Z-1836-2020·Announced 2020-05-06

Radiometer ABL800 FLEX Blood Gas Analyzer Recall for Power Supply Defect

Radiometer Medical ApS is recalling two ABL800 FLEX analyzers in California due to a power supply defect that may cause treatment delays and serious health risks.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the defect could result in 'severe impairment of cardiac function' and 'cardiac arrhythmias,' which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4.

Plain-English summary

Radiometer Medical ApS is recalling two units of the ABL800 FLEX blood gas analyzer (model numbers 393-800 and 393-801) in the United States. The affected units were distributed in the state of California and have serial numbers 902-754R2692N002 and 902-754R2692N001.

The recall was initiated after an internal investigation determined that an incorrect component was used within the power supply of these devices. This defect may cause a short circuit within the power supply, resulting in a delay in patient treatment. The source text notes that such delays could result in a range of risks, including cyanosis, low blood pressure, cardiac arrhythmias, and severe impairment of cardiac function.

Healthcare facilities and users should identify the affected units by checking the serial numbers and model numbers listed above. Users should contact Radiometer Medical ApS for instructions on how to proceed with the recall and replacement or repair of the devices.

The recalled product

Product: ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Manufacturer: Radiometer Medical ApS
Category: Medical Device — Blood Gas Analyzer
Hazard: electrical-short-circuit
treatment-delay
cardiac-arrhythmia
Affected units: 2

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)

Serial Numbers: 902-754R2692N002 and 902-754R2692N001

Distribution

Distributed in 2 states:

Same manufacturer · Radiometer Medical ApS

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