Z-0010-2019Class II

ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated...

Name: Z-0010-2019 ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated...
Creator: Radiometer America Inc
Published: 2018-05-25
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2018-05-25 / Terminated / root cause: design

FDA source

Radiometer America Inc began a recall of ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases... on 2018-05-25. FDA classified it as Class II and gives the reason as "The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0010-2019
Classification: Class II
Status: Terminated
Initiated: 2018-05-25
Posted: 2018-10-01
Terminated: 2020-11-06
Recalling firm: Radiometer America, Inc
Product: ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse Immediately after lifts the inlet and quickly closes it again
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Radiometer America, Inc., notified customers via letter dated 05/25/2015. The letter provided the following: Reason for recall, Affect product description and codes, Risk for the patient, What customers must do, Countermeasure provided by Radiometer, contact information and Response Form. The customers were instructed to do the following: 1. Inform users of the ABL90 FLEX analyzer that the inlet is not to be repeatedly lifted and closed. If this does happen, the easiest way to reset the analyzer flow selector manually is to re-install the solution pack. Follow the procedure described in the IFU for installation of a solution pack. You may re-use the same solution pack. 2. We recommend that you review previous results, where cNa+ and cCl- results are off from the expected results with the values found in table 1. 3. Complete the recall response fax form (last page of this customer advisory letter) and submit to your Radiometer representative via Fax to:714 582 0806. If you have any questions, please contact your Radiometer representative or Quality Assurance/ Regulatory Affairs Manager at 1-800-736-0600 opt.4.
Quantity in commerce: 12,102
Distribution: US Distribution and Internationally to Canada.
Product codes and lots: ABL90 FLEX analyzers with software versions 3.3MR1 or below.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0010-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0010-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01

Product code JJE

K120197Class IIAbl90 FlexRadiometer Medical Aps / cleared 2012-03-19

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)