Z-1463-2017Class II

The ABL800 Model#:All

Name: Z-1463-2017 The ABL800 Model#:All
Creator: Radiometer America Inc
Published: 2017-01-26
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2017-01-26 / Terminated / root cause: design

FDA source

Radiometer America Inc began a recall of The ABL800 Model#:All on 2017-01-26. FDA classified it as Class II and gives the reason as "Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1463-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-26
Posted: 2017-03-14
Terminated: 2018-02-20
Recalling firm: Radiometer America, Inc
Product: The ABL800 Model#:All
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Root cause tag: design
FDA root cause: Device Design
Action: Customer notification letters were sent 01/27/16. The letter provided the following instructions: The firm recommends that customers ensure that operators and clinicians using the "cord blood sample results from a HIS/LIS or a middleware system to determine treatment are made aware that arterial or venous is not transmitted. An upgraded version of the ABL90 and ABL800 series software will ensure that the full sample type cord blood arterial and cord blood venous will be transmitted to the HIS/LIS or middleware system. The new software version will be installed by local engineer when available. If not the end user customers are instruction to provide a copy of the recall notification letter to the end user. Any questions regarding this letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1.
Quantity in commerce: 17,522
Distribution: U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
Product codes and lots: The affected analyzers are serial numbers 393-090R0027N001 to present.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1463-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1462-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-14
Z-1463-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-14

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)