Radiometer America Inc: Medical Device Recall in 2017 - (Recall #: Z-1462-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.

Product Classification:

Class II

Date Initiated: January 26, 2017

Date Posted: March 22, 2017

Recall Number: Z-1462-2017

Event ID: 76339

Reason for Recall:

Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

Status: Terminated

Product Quantity: 9,688

Code Information:

The affected analyzers are serial numbers 393-090R0027N001 to present.

Distribution Pattern:

U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.

Voluntary or Mandated:

Voluntary: Firm initiated