Z-1046-2015Class II

ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases...

Name: Z-1046-2015 ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases...
Creator: Radiometer America Inc
Published: 2014-12-08
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2014-12-08 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry... on 2014-12-08. FDA classified it as Class II and gives the reason as "The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result". 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-1046-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-08
Posted: 2015-02-09
Terminated: 2015-09-23
Recalling firm: Radiometer America, Inc
Product: ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.
Root cause tag: software
FDA root cause: Software design
Action: Radiometer sent a Field Safety Notice dated December 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. What you should do short term: " Please ensure that the operator always closes the inlet when prompted by the analyzer, as per the labeling. " In case the inlet, by mistake, is not closed as per the labeling, please ensure that the following is carried out before measuring a patient sample: " Close the inlet and wait for the analyzer to go to READY (approximately five minutes) " Open the inlet and then close again (to initiate a Rinse) " Wait for the analyzer to go to READY (approximately 1 minutes) " Please return the confirmation fax form no. 1 to your RADIOMETER representative when the above actions have been implemented Final Solution provided by RADIOMETER: A mechanism will be provided in an upgraded version of the analyzer software to eliminate the possibility of this error. The new software version will be installed by your local engineer when available. Customers were instructed to ensure that this letter is distributed to the final end-user. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, opt 4.
Quantity in commerce: 5002 units
Distribution: Worldwide Distribution -USA including CT, MN, FL, CA, PA, NY, KY, MA, WA, MI, TX, NC, IL, OH, SC, OK, NJ, MD, VA, UT, AL, NM, GA, LA, OR, IN, WI, AZ, ND, CO, MO, WV, ID, TN, VT, NE, IA, NH, MS, ME, AR and Internationally to Canada, Australia, Austria , China, Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovenia, United Arab Emirates, Bolivia, Brazil, Indonesia, Israel, Kuwait, Malaysia, Mexico, Peru, Qatar, Saudi Arabia, Serbia and Montenegro, Syrian Arab Republic, Thailand, Vietnam, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Republic of Korea, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
Product codes and lots: Model number 393-090 (instrument). The affected analyzers are serial numbers 393-090R0027N001 to present.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1046-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1046-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-03

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)