Class II — Potential Health Hazard

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

ABL800 analyzer Recalled by Radiometer America Inc Due to The analyzer software may cause a mis-match of...

Date: July 3, 2018
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

ABL800 analyzer, model numbers 393-800 and 393-801.

Quantity: 2,131 analyzers

Why Was This Recalled?

The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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