| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01237-1 |
| Product Name/Description |
Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). An in vitro diagnostic medical device (IVD)
Siemens Material Number: 10310323
Lot Numbers: AQC/19516, AQC/19616, AQC/20816, AQC/20916, AQC/21016, AQC/21416, AQC/21516
ARTG Number: 185171 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified that certain lots of AQC have been incorrectly value assigned resulting in a +8 g/L bias for Level 1 tHb on RAPIDPoint 400/405/500 systems. Some users are reporting higher than expected results for this AQC level. Since the mis-assigned value is within the allowable range, there are no error flags. Customers who use Rilibak ranges or have tightened the AQC ranges may see a failed AQC error code. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that if the Quality Control values are recovering within range, users may continue to use the current stock of AQC cartridges that they have from these lots. For users experiencing tHb running high for AQC Level 1, a suggested workaround is to reset the target tHb value for Level 1 as 188 g/L, while using the impacted cartridges.
Siemens is recommending users review the letter with their Medical Director.
This action has been closed out on the 12/11/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |