Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15014 |
| Brand Name: | Radiometer pCO2 membrane (D788) for ABL7/8xx analyzers |
| Model: | Catalogue: 942-063 |
| Affected: | all lots |
| Software version: | |
| Recalling Organisation: | Radiometer Pacific Suite 1 1/30 Benedicts Street Eden Terrace Auckland 1010 |
| Contact Information: | 0800 723 722 |
| Manufacturer: | Radiometer Medical ApS |
| Issue: | Possible negative bias on pCO2 result on both blood and QC after membrane replacement. This bias can be seen after the replacement of the membrane. Update: The temporary countermeasures, regarding the additional requirement for manually narrowing the QC ranges for pCO2 and also performing extra QC measurements as communicated in July 2013 are no longer required and may be revoked upon installation of the improved sealing ring on the pH electrodes in ABL700 and ABL800 Series Analyzers. 01-02-2017: This notification is to inform you that your Radiometer representative has now installed the improved sealing ring for the pH electrode in your ABL700 and/or ABL800 series analysers. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/11/2016 |
