| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00066-1 |
| Product Name/Description |
RSR LEM25 RiaRSR VGCC Ab Kit - Anti-human IgG. An in vitro diagnostic medical device (IVD).
Kit Lot Number: LK245
Anti-human IgG Lot: 28LGa
Exp: 01/03/2024
ARTG 199521
(Abacus dx Pty Ltd - Clinical chemistry autoimmune IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
RSR Limited has received reports that a slight increase in the total counts for the NSB tracer has been seen. This in turn has led to a decrease in the concentration positive control which means that the positive control is out of the range recorded on the Quality Control Record Sheet supplied by RSR Ltd and thus assays are being classed as invalid. Use of affected kits may result in invalid patient results as the positive control will be out of range. This recall does not affect any other lot of the VGCC Ab Kit.
RSR Limited has identified that this issue is due to with the following kit component:
Anti-human lgG Lot: 28LGa Expiry date: 01 March 2024 |
| Recall Action |
Recall |
| Recall Action Instructions |
Cease using the affected RiaRSR VGCC Ab kit lot LK245.
Check any results generated by the affected kits.
- If the positive control concentration is within the kit specification then any results produced by these kits is valid.
- If the positive control concentration is out with the kit specification, please send your local distributor your data with a request for any replacement kits.
Identify any unused affected kits and discard the anti-human lgG.
Abacus dx will provide replacements and will confirm if the manufacturer wants the affected stock back or if the customer can destroy it. |
| Contact Information |
1800 222 287 - Abacus dx |