Z-2320-2019Class II

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

Name: Z-2320-2019 ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Creator: Radiometer America Inc
Published: 2019-07-10
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2019-07-10 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 on 2019-07-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2320-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-10
Posted: 2019-08-22
Terminated: 2022-06-13
Recalling firm: Radiometer America, Inc
Product: ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Product code: CEM Electrode, Ion Specific, Potassium
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.
Root cause tag: software
FDA root cause: Software design
Action: On (date), the firm will email a "Urgent Field Safety Notice" to all customers and will follow-up by mailing a copy of the "Urgent Field Safety Notice" to all customers via Federal Express with tracking and proof of delivery. The Urgent Field Safety Notice ask customers to do the following: 1. Check which version of the operating system (OS) is currently installed on your analyzer: o Logon to the analyzer o Touch Menu, Utilities, Temporary shutdown, and then Confirm o During the shutdown process the analyzer displays the version of OS installed " If the OS version is one of the following your analyzer is affected by the vulnerability: RXPE - UIM2743 v1.3.xxxxxx or RXPE-UIM910v1.3.xxxxxx 2. If your analyzer is found to be affected by the vulnerability the following options must be applied: Short term: If your analyzer is connected to a network and your IT department assesses that the Hospital Firewall and Network settings prevent a remote attacker from connecting to the analyzer to exploit the vulnerability, you may decide to keep the analyzer connected. Otherwise, we recommend disconnecting it until one of the long term countermeasures below has been implemented. Long term: Countermeasure 1: Contact your Radiometer representative to have the RXPE Security patch update installed on your analyzer. (Note: Microsoft does not support Windows XP anymore. However, Microsoft has extraordinarily released a patch for this particular vulnerability.) or Countermeasure 2: Contact your Radiometer representative to receive a quote for an upgrade to latest OS (Windows 7 embedded) from Radiometer, which is supported by Microsoft. 3.Please complete the Recall Response Form (last page of the customer advisory letter) and return it to your Radiometer representative. 4.Please Note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-users. If you have questions, please contact Radiometer
Quantity in commerce: 13,042 units
Distribution: 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
Product codes and lots: All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2320-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2320-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22

Product code CEM

K092686Class IIAbl90 Flex SeriesRadiometer Medical Aps / cleared 2010-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)