Z-1654-2008

ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)

Name: Z-1654-2008 ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)
Creator: Radiometer America Inc
Published: 2008-01-18
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2008-01-18 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device) on 2008-01-18. The reason FDA records is "Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to...". 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-1654-2008
Status: Terminated
Initiated: 2008-01-18
Posted: 2015-06-25
Terminated: 2012-02-24
Recalling firm: Radiometer America, Inc
Product: ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.
Root cause tag: software
FDA root cause: Software design
Action: On February 28, 2008, a Field Action Notes Letter was issued advising them about a Mandatory Software Update. Customers were notified of the problem by fax and letter (Fed Ex). The Recall Letter instructed the user to disable the parameter bar feature and only rely on the traffic light system indicator which properly indicates system errors. The letter includes instructions to temporarily fix the problem and notice of a update of the software module that updates the parameter bar. If you have any questions contact Vincent Sigmund at (440)-871-8900 ext. 209.
Quantity in commerce: 2481
Distribution: Worldwide Distribution - USA and Canada - Products were sold in all fifty (50) US States. including twenty-nine 29 government accounts and 138 Canadian accounts.
Product codes and lots: ABL800 Flex (902-754)

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)