Z-0231-2018Class II

ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the...

Name: Z-0231-2018 ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the...
Creator: Radiometer America Inc
Published: 2017-10-24
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2017-10-24 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac... on 2017-10-24. FDA classified it as Class II and gives the reason as "Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer". 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-0231-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Posted: 2017-12-08
Terminated: 2023-10-10
Recalling firm: Radiometer America, Inc
Product: ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Customer were notified via letter using FedEx tracking on approximately October 24, 2017. Instructions included verification that the test results and the patient and demographic information matches, that Radiometer America is working to improve the software to remove the possibility of the code being misinterpreted, and to notify customers if the product has been further distributed. For further questions, please call (800) 736-0600.
Quantity in commerce: 1,749 analyzers
Distribution: USA (nationwide) to: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Distributed internationally to Canada.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0231-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0231-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-08

Product code CHL

K041874Class IIAbl800 FlexRadiometer Medical Aps / cleared 2004-10-08

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)