Z-0748-2016Class II

AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers

Name: Z-0748-2016 AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers
Creator: Radiometer America Inc
Published: 2015-12-29
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2015-12-29 / Terminated / root cause: design

FDA source

Radiometer America Inc began a recall of AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers on 2015-12-29. FDA classified it as Class II and gives the reason as "The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could...". 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-0748-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-29
Posted: 2016-02-03
Terminated: 2016-03-29
Recalling firm: Radiometer America, Inc
Product: AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were sent a notification letter on 12/29/15. The notification states that the AQURE System can be used, but to eliminate the potential confusion, blank fields for sample type are to be interpreted as not specified. Customers are told that a Radiometer representative will be in contact to schedule a visit or a remote session. During the visit or remote session the representative will run a database script on the AQURE system which will serve for two purposes: 1. Update existing patient results where the sample type field is blank to include Not specified. 2. Install a so-called database-trigger, which will include the text Not specified in a blank sample type field for future patient results. An upgraded version of the AQURE software will include modified device drivers to ensure that Not specified is inserted if the device transmits an empty field for sample type. The new software version will be installed by local engineer when available.
Quantity in commerce: 375
Distribution: Worldwide Distribution-US (nationwide) including the states of PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.
Product codes and lots: Model Number: 933-599 Version 1.8.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0748-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0748-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-03

Product code CHL

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)