| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00758-1 |
| Product Name/Description |
Multiple Cryostat Devices.
Multiple product names and product codes
ARTG 210991
(Leica Biosystems Melbourne Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
The Leica Biosystems recognised that some customers were using flammable freezing sprays within the cryostat chamber. The use of flammable freezing spray can potentially lead to explosion inside the cryostat chamber and result in burns of the user. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to label the instrument with the adhesive label provided with the customer letter and add the safety amendment to the Instruction for Use (IFU). |
| Contact Information |
Ivana Ng +65 6550 5501
Yuvesh Jain 03 9211 7400 |