FDA Medical Device Recalls (openFDA)
Radiometer America Inc: AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
- Recall number
- Z-0748-2016
- Recalling firm
- Radiometer America Inc
- Product
- AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
- Status
- Terminated
- Initiated
- 2015-12-29
- Posted
- 2016-02-03
- Terminated
- 2016-03-29
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Model Number: 933-599 Version 1.8.3
- 510(k) numbers
- ["K130144","K142898","K151856"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 3010420736
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28