| TGA Action ID |
RC-2026-RN-00703-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Dako Slide Racks - 10 pieces CoverStainer. An in vitro diagnostic medical device (IVD).
Part Number: CS11930
Lot Numbers: 174382, 174383 |
| ARTG Number |
181957 |
| Unique Device Identifier (UDI) |
CS11930 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Agilent has identified moulding burrs on certain lots (174382 and 174383) of the Dako Slide Racks, 10 pcs, CoverStainer. A burr is excess plastic material that may remain on the slide rack following manufacturing. In some cases, the burr may prevent the slide rack from being properly inserted into the Dako CoverStainer instrument, preventing initiation of a staining run. |
| Instructions for Customers/Users |
Customers are to:
- Identify affected lots 174382 and 174383.
- Inspect affected slide racks for burrs by inserting the empty rack into the Dako CoverStainer Rack Loading Tray.
- Continue using burr-free slide racks and discard any racks containing burrs.
- Confirm the quantity of affected products held, as outlined in the customer letter. |
| Action Commencement Date |
15/09/2026 |
| Responsible Entity |
|
| Contact Information |
enia.kakaflikas@agilent.com -
Agilent Technologies Australia |