Recall Z-0150-2010 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Sendx Medical Inc
ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for u
| Date | Nov 10, 2009 (initiated Feb 20, 2009) |
| Status | Terminated |
| Reason | Inverness have recently become aware of a potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the |
| Root cause | Other |
| Action | Radiometer sent out a letter to consignees informing them of public reason for recall, and telling them that they have provided a copy of the upgrade software and instructions to correct this potential problem immediately. Software upgrade instructions were included with the recall letter. Consignees were informed that if they preferred that their local service representative perform the upgrade, to follow the Instructions for disabling auto upload of patients records. SOFTWARE UPGRADE INSTRUCTIONS: The upgrade software must be installed via the Software Upgrade option under Menu>Utilities> |
| Quantity | 317 |
| Distribution | Domestically and Worldwide: Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and Denmark Domestically to OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080370 | ABL 80 CO-OX SYSTEM Sendx Medical, Inc., Jul 31, 2008 |