Recall Z-2320-2019— Radiometer America Inc

Name: FDA recall Z-2320-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-10

Class II · Terminated

Class II FDA medical device recall by Radiometer America Inc, initiated 2019-07-10, terminated 2022-06-13. It names one FDA 510(k) clearance: K092686. Product: ABL90 FLEX Analyzer REF 393090 UDI:05700693930909. 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: Radiometer America Inc
Classification: Class II
Status: Terminated
Initiated: 2019-07-10
Terminated: 2022-06-13
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K092686 — ABL90 FLEX SERIESRadiometer Medical Aps·cleared 2010-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.