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 REF 393090 UDI:05700693930909 Recalled by Radiometer America Inc Due to Software Security; The action is being initiated because...

Date: July 10, 2019
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 REF 393090 UDI:05700693930909

Quantity: 13,042 units

Why Was This Recalled?

Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.

Where Was This Sold?

This product was distributed to 36 states: AL, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TX, VT, VA, WA, WV, WI

Affected (36 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