Z-2112-2011

ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped...

Name: Z-2112-2011 ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped...
Creator: Radiometer America Inc
Published: 2011-01-12
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2011-01-12 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous... on 2011-01-12. The reason FDA records is "Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the...". 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-2112-2011
Status: Terminated
Initiated: 2011-01-12
Posted: 2011-04-28
Terminated: 2012-05-09
Recalling firm: Radiometer America, Inc
Product: ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If the device operator/user ignores the error message and continues to obtain biased measuring results using the
Root cause tag: software
FDA root cause: Software design
Action: The firm, Radiometer America, sent two Urgent "Medical Device Field Correction" letters issued on February 4, and on February 24th, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to replace the sensor cassette. In order to prevent this situation from occurring, the firm informed the customers in the recall/correction notification that they intend to upgrade all ABL 90 Flex analyzers to a new software version. The new software will perform a check during a normal system FLUSH in order to allow the analyzer to detect the bias and will notify the customer immediately of this condition and will automatically disable the cassette thus preventing further use. The letter goes on to remind the device customers that until such time as the software upgrade is installed, they should make sure to adhere to the procedures stated in the Reference Manual which call for the replacement of the sensor cassette immediately upon receiving message #1310. The letter further instructs the customer to complete and return the attached FAX RETURN FORM via fax to 440-871-0463. The letter also states that the expected release date for the new software should be sometime in the second half of February 2011. If you have any questions regarding this letter, or the upgrade, please contact Technical Support staff at 1-800-736-0600 Opt 4.
Quantity in commerce: 32 units were distributed in the U. S. and 533 units were distributed world-wide
Distribution: Worldwide distribution: USA including states of CA, DC, PA, MN, NY, NJ, TX, OH, MO, WI, UT, and MI; and country of Canada.
Product codes and lots: Part Number: 393-090, all production runs for Serial Numbers: 393-090R0026N0010 to 393-090R0082N0005.

Product code CEM

K092686Class IIAbl90 Flex SeriesRadiometer Medical Aps / cleared 2010-08-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)