CLASS II ONGOING Device recall · Reported 6 May 2020 · FDA Enforcement Report

ABL800 FLEX recalled by Radiometer Medical ApS

Radiometer Medical ApS is recalling ABL800 FLEX, distributed in California. The recall was initiated on 6 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 902-754R2692N002 and 902-754R2692N001

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1836-2020
FDA event ID: 85166
Recalling firm: Radiometer Medical ApS, Bronshoj, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 6 Mar 2020
FDA classified: 30 Apr 2020
Reported: 6 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Mar 2020	Recall initiated by company
30 Apr 2020	Classified by FDA	+55 days
6 May 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.

Product as listed by the FDA

ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

Where it was distributed

US: in the state of California

California

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US: in the state of California

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Radiometer Medical ApS

All 24

Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Device	CLASS II	Radiometer ABL90 Series - Radiometer ABL90 FLEX recalled	Radiometer Medical ApS	Device Malfunction	49 states
26 Apr 2023Device	CLASS II	Aqure REF 933-599 Software Versions 2.5.2 recalled	Radiometer Medical ApS	Packaging Defects	Nationwide
13 Jul 2022Device	CLASS II	ABL800 Flex Analyzer recalled by Radiometer Medical ApS	Radiometer Medical ApS	Other	Nationwide
25 May 2022Device	CLASS II	Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL recalled	Radiometer Medical ApS	Sterility	Nationwide
23 Jun 2021Device	CLASS II	Radiometer ABL90 Flex Plus Analyzer with E3800 PC units recalled	Radiometer Medical ApS	Other	Nationwide

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