| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00610-1 |
| Product Name/Description |
Access Folate and Access TSH Reagent Packs when used on DxI 9000 Access Immunoassay Analyser. An in vitro diagnostic medical device (IVD)
Reference numbers: A98032 and B63284
Multiple lot numbers
ARTG 192076
(Beckman Coulter Australia Pty Ltd - Clinical chemistry vitamin and mineral IVDs)
ARTG 177999
(Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs)
ARTG 227952
(Beckman Coulter Australia Pty Ltd - Clinical chemistry hormone IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/07/2023 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has determined that the DxI 9000 Access Immunoassay Analyser reagent pipettors may not fully puncture through the elastomeric coating on the Access Folate and Access TSH reagent pack lots listed in the table above.
This issue is caused by the elastomeric coating that was used to manufacture the affected reagents.
No other versions of instruments are affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Discontinue use of the affected Access Folate and Access TSH reagent lots with the DxI 9000 Access Immunoassay Analyser.
Contact the local Beckman Coulter representative for product replacement requests. |
| Contact Information |
1800 060 881 - Beckman Coulter Support Centre |