Radiometer America Inc: Medical Device Recall in 2016 - (Recall #: Z-0748-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

Product Classification:

Class II

Date Initiated: December 29, 2015

Date Posted: February 10, 2016

Recall Number: Z-0748-2016

Event ID: 72959

Reason for Recall:

The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.

Status: Terminated

Product Quantity: 375

Code Information:

Model Number: 933-599 Version 1.8.3

Distribution Pattern:

Worldwide Distribution-US (nationwide) including the states of PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.

Voluntary or Mandated:

Voluntary: Firm initiated