| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00900-1 |
| Product Name/Description |
Radiometer ABL800 FLEX series blood gas analysers with Crea module. An in vitro diagnostic medical device (IVD)
ARTG Number: 228382
(Radiometer Pacific Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has recently become aware that the ABL800 series analysers that measure cCrea may potentially report lower than expected cCrea results on patient samples.
The difference has been reported to be as high as -28%.
Currently, this problem may not identified by running the QC, as the QC will be lower, but still within range.
The underestimated creatinine occurs specifically when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are = 230 µM of a specified insert interval for AC6+L1 with insert limits 210–290 µM. Ultimately, a lower read-out on patient samples on ABL8X7 is observed.
This issue may lead to erroneous measurement values for cCrea, and may lead to no detection of renal insufficiency or underestimation of moderate to severe renal failure. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Radiometer requests that users do not report cCrea results until they have verified the performance of the membrane units as described in the Customer Letter.
Radiometer is advising that they are improving the cCrea membranes and will advise users accordingly when interim measures are no longer required.
This action has been closed out on 14/08/2019 |
| Contact Information |
1800 247 254 - Radiometer Pacific |