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 Recalled by Radiometer America Inc Due to The ABL90 analyzer does not always use the...

Date: December 8, 2014
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; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

Quantity: 5002 units

Why Was This Recalled?

The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.

Where Was This Sold?

This product was distributed to 41 states: AL, AZ, AR, 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

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