| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00470-1 |
| Product Name/Description |
ABL800 Basic and ABL8XX FLEX analysers. An in vitro diagnostic medical device (IVD).
All software versions
All serial Numbers
ARTG 228382
(Radiometer Pacific Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical study was carried out based on reports from internal and external users regarding pH sensitivity and pH drift errors for calibrations and measured QC pH values out of range.
The study concludes that there is a possibility of reporting biased out-of-specification pH results on blood samples.
This may occur if the calibration solution's pH value decreases during the in-use period due to bacterial growth in the calibration solution bottles CAL1 and/or CAL2.
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. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
With immediate effect, Radiometer requests that users implement either “Procedure 1” for customers who run daily quality controls or “Procedure 2” for customers who do not. The procedures are described within the Customer Letter.
This must be carried out regardless of which patient groups are measured on the analyser. It will ensure that biased out-of-specification pH results that may lead to the risks above are not reported. |
| Contact Information |
1800 247 254 - Radiometer |