| TGA Action ID |
RC-2025-RN-00501-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VIDAS Lyme IgM. An in vitro diagnostic medical device (IVD)
Reference Number: 30319
Batch Number: 1010782000
Expiry Date: 20 June 2025 |
| ARTG Number |
355333 |
| Unique Device Identifier (UDI) |
03573026 265083, |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
BioMérieux has received customer complaints from the field related to invalid calibrations when using VIDAS Lyme IgM ref. 30319. The invalid calibration problem is due to the S1 being out of range too low.
When the calibration is invalid, a message is displayed on the VIDAS report showing that the calibration is invalid and the customer should not release patient results if they are preceded by an invalid calibration.
Invalid calibration due to S1 standard high out-of-low is associated with a potential risk of delayed patient results. |
| Instructions for Customers/Users |
Customers are to either order a new kit VIDAS LYME IGM (ref. 30319) or replace kit of lots 1010782000 by another one in their inventory, then Discard the kits of lots 1010782000 remaining.
Customers are reminded that as per the IFU calibration must be performed each time a new lot is opened using the standard provided in the kit, after the master lot data have been entered. Calibration should then be performed every 28 days.
This action has been finalised on 22/9/2025. |
| Action Commencement Date |
3/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 333 421 - Biomerieux Australia |