| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00470-1 |
| Product Name/Description |
RAPIDQC Complete Solution Level 3. An in vitro diagnostic medical device (IVD)
Siemens Material Number (SMN): 10309927
Lot Numbers: 363403, 363404, 363501
ARTG Number: 185171 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified that the pH parameter may recover low within range or lower than expected with the affected lots of Level 3 RAPIDQC Complete product on both the RAPIDPoint and the RAPIDLab blood gas systems. The issue identified represents a negligible risk to patients and does not pose any health or safety risk to operators. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is advising users that if the QC values are recovering within range, the lots can continue to be used. If the affected lots are not recovering within range, the lots will be replaced with unaffected stock.
This action has been closed out on 08/11/2018 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |