| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00145-1 |
| Product Name/Description |
Access Substrate 4 x 130ml. An in vitro diagnostic medical device (IVD).
Includes the Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems
Part Number: 81906
Multiple Lot and Expiry Dates
ARTG 229315
(Beckman Coulter Australia Pty Ltd - General laboratory reagent and consumables IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has been made aware through customer feedback that they have received Access Substrate bottles that do not contain labels.
If the substrate label is missing, the system will not recognise the bottle and it cannot be used.
The reporting of patient results may be delayed due to the time required for a new substrate bottle to equilibrate to room temperature. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to:
•Verify upon receipt that all Access substrate bottles have a label
•Discard all Access substrate bottles without labels, according to their local regulations
•Contact their Beckman Coulter representative and request a replacement order if Access substrate bottles are missing a label. |
| Contact Information |
1800 060 881 - Customer Support Centre |