Radiometer America Inc: Medical Device Recall in 2018 - (Recall #: Z-0010-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Product Classification:

Class II

Date Initiated: May 25, 2018

Date Posted: October 10, 2018

Recall Number: Z-0010-2019

Event ID: 80718

Reason for Recall:

The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again

Status: Terminated

Product Quantity: 12,102

Code Information:

ABL90 FLEX analyzers with software versions 3.3MR1 or below.

Distribution Pattern:

US Distribution and Internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated