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Recall Observatory FDA recall evidence

Device product

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

Z-2320-2019

July 10, 2019

Class II

Product summary

Firm
Radiometer America Inc
Event
Event 83312
Status
Terminated
Classification
Class II
Quantity
13,042 units
Official record key
device-enforcement:Z-2320-2019

Official wording

Reason: 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.

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software security vulnerabilities with the firm's analyzer operating system, which may cause