Z-0682-2019Class II

ABL800 analyzer, model numbers 393-800 and 393-801

Name: Z-0682-2019 ABL800 analyzer, model numbers 393-800 and 393-801
Creator: Radiometer America Inc
Published: 2018-07-03
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2018-07-03 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of ABL800 analyzer, model numbers 393-800 and 393-801 on 2018-07-03. FDA classified it as Class II and gives the reason as "The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0682-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-03
Posted: 2018-12-22
Terminated: 2023-08-30
Recalling firm: Radiometer America, Inc
Product: ABL800 analyzer, model numbers 393-800 and 393-801.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued letters dated 7/3/2018 on 7/3/2018 via FedEx.
Quantity in commerce: 2,131 analyzers
Distribution: Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
Product codes and lots: Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0682-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0682-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22

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)