| TGA Action ID |
RC-2025-RN-00329-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ABL800 Basic and ABL8XX FLEX analysers. An in vitro diagnostic medical device (IVD).
All Serial Numbers |
| ARTG Number |
228382, 485466 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
An internal technical study regarding pH sensitivity and pH drift errors for calibrations and measured QC pH values out of range concluded that there is a probability of reporting biased out-of-specification pH results on blood samples.
The described error may lead to a fetal patient with a scalp pH measurement result in the severe acidosis (<7.20) range being diagnosed as having moderate acidosis. This may put the fetal patient at risk for not being delivered immediately by either instrumental vaginal delivery or urgent caesarean section and thus being at risk for experiencing permanent organ damage, including brain damage, due to hypoxia.
Radiometer has released an update to the software, which effectively eliminates the risk for the patient, described in the previous communication.
Update 2/6/2025:
The permanent solution provided by the manufacturer for analysers running with Windows 7 or Windows10 is a software upgrade to V6.20 MR2. This market action is still outstanding, and target completion is March 2026.
For customers with ABL8XX running with Windows XPE (software versions below V6.20 MR2), continue using one of the manual procedures implemented as per the communication previously distributed. There is no permanent solution yet for these analysers.
Update 9/12/2025:
Radiometer has released a “Supplement to the ABL800 FLEX and BASIC Operator’s manual for analysers running Windows XP” to include the procedures communicated in May 2024. |
| Instructions for Customers/Users |
Customers are to continue using workaround solutions, as per the customer letter, before the implementation of software update.
A Radiometer representative will either schedule a visit, or a remote session to upgrade the software.
Update 2/6/2025:
- Radiometer requests that customers continue using one of the manual procedures implemented as per the communication distributed in June 2024 and March 2025.
- Radiometer is conducting further investigations to identify permanent countermeasures for analysers running with Windows XPE.
- A Radiometer representative will contact customers with further communication.
Update 09/12/2025:
- Continue using one of the manual procedures which are provided in the “Supplement to the ABL800 FLEX and BASIC Operator’s manual for analysers running Windows XP”. |
| Action Commencement Date |
27/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 247 254 - Radiometer Pacific representative |