Z-0816-2014Class II

ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that...

Name: Z-0816-2014 ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that...
Creator: Radiometer America Inc
Published: 2013-10-15
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2013-10-15 / Terminated

FDA source

Radiometer America Inc began a recall of ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose... on 2013-10-15. FDA classified it as Class II and gives the reason as "RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0816-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-15
Posted: 2014-01-23
Terminated: 2014-06-19
Recalling firm: Radiometer America, Inc
Product: ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
FDA root cause: Other
Action: Radiometer sent an Urgent Medical Device Recall letter dated November 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check all of their ABL90 FLEX analyzers and ensure that the analyzer is placed on a horizontal platform/table. If the analyzer is placed on a roll stand, please ensure that the support plate is aligned horizontally and locked in this position. Customers were asked to complete and fax the accompanying acknowledgment form in order to confirm their receipt of this field safety notice. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900.
Quantity in commerce: Total 3414 (US 524, CA 31, ROW 2859)
Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.
Product codes and lots: Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0816-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0816-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code JGS

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)