| TGA Action ID |
RC-2026-RN-00208-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Artisan Stain Kits. An in vitro diagnostic medical device (IVD).
Artisan Periodic Acid-Schiff Stain Kit
Part Number: AR165
Multiple affected lot numbers.
Artisan Alcian Blue/PAS Stain Kit
Part Number: AR169
Multiple affected lot numbers.
Artisan PAS-Green Stain Kit
Part Number: AR172
Multiple affected lot numbers.
Artisan Alcian Blue/PAS/Hematoxylin Stain Kit
Part Number: AR178
Multiple affected lot numbers.
|
| ARTG Number |
196077 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Agilent has identified weak or absent staining associated with specific lots of AR165, AR169, AR172 and AR178. In rare cases, this problem may impact staining performance. Weak or absent staining is readily detectable when the recommendations in the Instructions for Use (IFU) are followed.
These products require the use of appropriate controls with every staining run. It is important to continue running the required controls concurrently with patient specimens, following the same protocol, as specified in the IFU. These controls will detect any staining performance problems. |
| Instructions for Customers/Users |
Customers should;
1. Please review the Artisan Periodic Acid-Schiff Stain Kits’ IFUs to ensure that all staining procedures are performed correctly. As stated in the product IFUs:
“… appropriate controls must be run simultaneously using the same protocol as the patient specimen. If unexpected staining is observed which cannot be explained by variations in laboratory procedures or improper storage, and a problem with the reagent is suspected contact Technical Support.”
2. If you have received an affected lot, as listed in Table 1 in the customer letter, please continue to test the product per the IFU. If you experience weak or absent staining, contact your local contact for technical support and troubleshooting assistance.
This action has been closed out on 20/07/2026 |
| Action Commencement Date |
27/03/2026 |
| Responsible Entity |
|
| Contact Information |
+61 395661723 - Enia Lucia |