Z-0190-2027

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses...

Name: Z-0190-2027 The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses...
Creator: Radiometer Medical ApS
Published: 2026-08-18
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2026-08-18 / Open, Classified

FDA source

Recall record

Recall number: Z-0190-2027
Status: Open, Classified
Initiated: 2026-08-18
Posted: 2026-10-15
Recalling firm: Radiometer Medical ApS
Product: The ABL90 FLEX and ABL90 FLEX PLUS analyzers are 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. These tests are only performed under a physician's order.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.
FDA root cause: No Marketing Application
Action: On 8/18/2026, correction notices were mailed or emailed to customers who were asked to take the actions listed in the correction notice. The firm updated intended use and instructions for use. In addition, the firm is developing an updated software version that will modify the analyzer configuration in accordance with the updated FDA clearances. Customers are asked to do the following: 1) Implement the requested changes to the setup of your analyzer(s) as stated in the correction letter. 2) Review the changes to the labeling for the analyzers as stated in the updated Instructions for Use. 3) Complete and return the Recall Response Form via email to [email protected] 4) If you are not the end user of the affected product, please ensure that this letter is distributed to the end user. If you have any questions, contact the firm at 1-800-736-0600 option 1, Monday - Friday 9am to 7pm (EST)
Quantity in commerce: 5395
Distribution: US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL, TX, GA, NC, PA, SC, MI, OK, WI, AR, MN, OR, UT, WA, SD, IN, TN, AZ, NE, WY, KY, AL, AK, ID, NJ, DE, MT, CT, MS, MO, VT, WV, IA, MD, KS, DC, NV, VA, NM, NH, ND, ME, HI, RI.
Product codes and lots: UDI-DI: 05700693930923, 05700693930909 Software versions 3.6 and lower. ABL90 FLEX PLUS Instructions for Use versions prior to: 996-223, Version: 202606O. ABL90 FLEX Instructions for Use versions prior to: 996-189, Version: 202606L

Product code CHL

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

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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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)