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 software version 2.7 MR3. The ABL90 FLEX analyzer Recalled by Radiometer America Inc Due to A customer has reported an error on an...

Date: July 5, 2012
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 software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.

Quantity: 1427 ABL 90 Instruments

Why Was This Recalled?

A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t

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