| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00447-1 |
| Product Name/Description |
Berichrom PAI (Plasmin activator inhibitors). An in vitro diagnostic medical device (IVD)
Catalogue number: OWOA15
Siemens material number: 10446642
Lot number: 541577 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
16/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
The incorrect Table of Assigned Values (TAV) was provided with the product. The use of the incorrect values for Standard 2 will result in slightly increase calibration curves, potentially resulting in decreased values for patient samples. The degree of deviation is less than 10 percent. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers who use the manual method to carry out the test are requested to use the assigned values provided in the recall correspondence. The values provided on the Lot Data CD for use with the BCS/BCS XP systems are correct. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |