Z-1836-2020Class II

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

Name: Z-1836-2020 ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Creator: Radiometer Medical ApS
Published: 2020-03-06
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2020-03-06 / Open, Classified / root cause: design

FDA source

Radiometer Medical ApS began a recall of ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 on 2020-03-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1836-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-03-06
Posted: 2020-05-01
Recalling firm: Radiometer Medical ApS
Product: ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 3/5/2020 a "Urgent: Medical device Recall" letter was hand delivered to effective consignees. In addition to providing information on the recall products, the customer notification as consignees to take the following actions: Solution provided by Radiometer: 1. Your Radiometer representative will exchange the power supply of your ABL800 analyzer at the earliest convenience. Your Actions: 1. Cease using the affected ABL800 analyzer and put it on quarantine. 2. Shut down the affected ABL800 analyzer and disconnect the power cord. 3. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative 4. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST.
Quantity in commerce: 2 units
Distribution: US: in the state of California
Product codes and lots: Serial Numbers: 902-754R2692N002 and 902-754R2692N001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1836-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1836-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-06	2020-04-30

Product code CHL

K041874Class IIAbl800 FlexRadiometer Medical Aps / cleared 2004-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)