| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01140-1 |
| Product Name/Description |
AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. An in vitro diagnostic medical device (IVD)
Multiple models and catalogue numbers
All serial numbers affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
If the AU5800 diluted detergent tank valve is not positioned to 'CLOSED' during the instrument 'measure' mode, diluted detergent will not be dispensed and may adversely affect washing of cuvettes, probes and mixing-bars. Inadequate washing of cuvettes, probes and mixing bars can cause falsely high or low results to be reported for a variety of tests. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is providing work around instructions to mitigate the issue and is asking customers to add a label to the diluted detergent tank identifying the "Open" and "Closed" orientation of the valve. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support |