| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01068-1 |
| Product Name/Description |
Low RNA Reagent Cassette; 40331. An in vitro diagnostic medical device (IVD)
Lot Numbers: C297749RL, C297192RL
Expiry date: 19-Sep-2024, 12-Sep-2024
ARTG 313500
(AusDiagnostics Pty Ltd - General laboratory reagent and consumables IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
AusDiagnostics has received a report stating that Batch C297749RL has a low oil level issue and C297192RL a low enzyme level issue.
The defect relating to low level oil was identified by one customer, the issue relating to low level enzyme was identified in-house.
Use of these batches of Low RNA Reagent Cassette – Ref. 40331 could result in delay in reporting patient results due to repeat runs been required.
To date, there have been no reports of adverse events related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately identify both affected lot numbers Batch C297749RL and batch C297192RL of Low RNA Reagent Cassette – Ref. 40331, quarantine them to prevent further use and safely dispose of them.
AusDiagnostics Pty ltd will provide replacement stock to customers free of charge after receipt of the acknowledgement form.
This action has been closed out on 18/3/2024. |
| Contact Information |
+612 9698 8030 - AusDiagnostics Pty Ltd |