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Terminated

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

FDA Recall Z-0748-2016 · Posted 2016-02-03

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2015-12-29
Date Terminated2016-03-29
Product Quantity375

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130144ABL90 FLEXRadiometer Medical Aps · 2013-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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