| TGA Action ID |
RC-2026-RN-00856-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Euroimmun IIFT: Legionella Mosaic 7 (IgAGM). An in vitro diagnostic medical device (IVD).
Product Code: FI 2150-1010-7 P
Lot number: T260619BM
Expiry Date: 18/12/2027 |
| ARTG Number |
225914 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Non-specific fluorescence has been observed on the Legionella pneumophila serogroup 1 and Legionella longbeachae biochips in the mosaic. Further testing using the quality control material supplied with the kit and previously characterised positive patient samples demonstrated reduced reactivity on both biochips compared with a previous lot of the same assay.
Reduced reactivity may result in failure to detect IgA, IgG and IgM antibodies against Legionella pneumophila serogroup 1 and Legionella longbeachae, potentially leading to false-negative results. Non-specific fluorescence may interfere with result interpretation and could lead to incorrect or inconclusive results. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock immediately and quarantine affected stock of lot number T260619BM on hand to prevent further use.
ESL Biosciences will arrange the return of affected stock on hand. A credit note will provided by ESL Biosciences for all kits supplied of the affected lot number. |
| Action Commencement Date |
26/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 9887 3700 - Ann Chang, ESL Biosciences ANZ |