Company: Radiometer America Inc
Date of Enforcement Report: 8/28/2019
Class II

PRODUCT

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

• Recall Number: Z-2320-2019

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.

RECALLING FIRM/MANUFACTURER

Radiometer America Inc on 7/10/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

13,042 units

DISTRIBUTION

US Nationwide and International