Radiometer America Inc: Medical Device Recall in 2019 - (Recall #: Z-2320-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

Product Classification:

Class II

Date Initiated: July 10, 2019

Date Posted: August 28, 2019

Recall Number: Z-2320-2019

Event ID: 83312

Reason for Recall:

Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.

Status: Terminated

Product Quantity: 13,042 units

Code Information:

All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX

Distribution Pattern:

US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico

Voluntary or Mandated:

Voluntary: Firm initiated