Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ABL90 FLEX Analyzer Radiometer Medical ApS Recalled by Radiometer America Inc Due to RADIOMETER become aware that if the ABL90 FLEX...

Date: October 15, 2013
Company: Radiometer America Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Radiometer America Inc directly.

Affected Products

ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

Quantity: Total 3414 (US 524, CA 31, ROW 2859)

Why Was This Recalled?

RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.

Where Was This Sold?

This product was distributed to 41 states: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI, DC

Affected (41 states)Not affected

About Radiometer America Inc

Radiometer America Inc has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report