Recall Z-0748-2016 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
| Date | Feb 3, 2016 (initiated Dec 29, 2015) |
| Status | Terminated |
| 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 |
| 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 Kingd |
| FDA record | Open on fda.gov |