| TGA Action ID |
RC-2025-RN-00484-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Wright's/Giemsa Stain 0.26%. An in vitro diagnostic medical device (IVD)
Item Code: 660-001, 660-005
Batch Number: 715604, 715605, 715583, 715586 |
| ARTG Number |
229435 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Wright's/Giemsa Stain 0.26% may potentially be contaminated with xylene (mixture of isomers). Contaminated product has a distinctive aromatic odour and may produce artefact and poor staining on the film.
Samples may show faint staining, and when mixed with aqueous buffer (as per the staining protocol), the mixture turns cloudy and the stain precipitates from the solution, resulting in macroscopic contamination of the slide (and rejection of the sample).
The contamination of the stain may cause samples to be rejected during processing, requiring new samples need to be tested. |
| Instructions for Customers/Users |
Customers are to immediately quarantine affected stock to prevent further use.
Return affected stock to the address in the customer letter.
Alternative batches of Wright’s/Giemsa Stain 0.26% (item code 660-001 or 660-005) are suitable replacements and are currently available for order. Contact Kinetik Pty Ltd to arrange for replacements.
This action has been closed out on 27/02/2026 |
| Action Commencement Date |
5/06/2025 |
| Responsible Entity |
|
| Contact Information |
07 3203 0401 - Kinetik Pty Ltd |