| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00497-1 |
| Product Name/Description |
Cholesterol. An in vitro diagnostic medical device (IVD)
Catalogue number: 981813
Lot number: WB28
UDI: (01)16438153818134(17)250331(10)WB28
Expiration date: 31.03.2025
ARTG 198365
(Thermo Fisher Scientific Australia Pty Ltd - Clinical chemistry substrate IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Thermo Fisher Scientific has become aware through customer complaint investigation that the Cholesterol reagent lot WB28 response levels have decreased over time.
This has resulted in decreased linearity at the high end (10 – 15 mmol/l) of Cholesterol measuring range. The reduced linearity may cause up to a 15% decrease in reported cholesterol results for patient samples within this concentration range. The problem is linked to a specific raw material lot used in the manufacturing of the impacted Cholesterol product lots.
To date no incidents or injuries to patients have been reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
- The affected Cholesterol reagent lots are to not being used for patient sample analysis on Indiko and Konelab analysers and should be discarded.
- The problem may result in “Factor limit max” error being triggered on Indiko analyser during calibration. Simultaneous to this error message, calibration automatic acceptance is changed to manual acceptance. Calibration should not be approved if errors have occurred.
- Replacements will be provided to customers with impacted products.
- Please discard the remaining stock of the affected product. |
| Contact Information |
1300 735 292 - ANZInfo@thermofisher.com - Thermo Fisher Customer Care Team |