FDA-Device2026-10-21Class IIPROCESSING DEFECT

Radiometer ABL90 FLEX analyzers recalled for inaccurate test results

OTHERNationwide distributionMedical devices

What this means

Radiometer Medical's ABL90 FLEX and ABL90 FLEX PLUS blood analyzers may produce inaccurate test results due to issues with how certain sample types and test parameters are configured. The company has identified that whole blood samples are no longer suitable for two specific tests (FHbF and ctBil), and reportable ranges for some other measurements need adjustment.

If your facility uses an ABL90 FLEX or ABL90 FLEX PLUS analyzer, contact Radiometer Medical for updated instructions and software
Update your analyzer to software version 3.7 or higher and follow the latest Instructions for Use
Review changes to sample types and reportable ranges before resuming affected tests

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

5395

Manufactured in

Akandevej 21, Bronshoj, Denmark

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0190-2027

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