| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00047-1 |
| Product Name/Description |
Alkaline Phosphatase (ALPAMP and ALPDEA), An in vitro diagnostic medical device (IVD)
Test code: ALPAMP
Catalogue number: 03035814
Siemens Material Number: 10309049
Lot numbers: 255406, 260121
Test code: ALPDEA
Catalogue number: 03036535
Siemens Material Number: 10341131
Lot number: 255465
ARTG 176331
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
The affected lots demonstrate an increased incidence of absorbance flags, (u, U) and //// errors. Absorbance flags u and U indicate abnormal high absorbance exceeding either the blank or sample limit. Absorbance flag //// indicates a calculation error and no result is generated by the system. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens Healthcare is advising customers to discontinue use and discard any affected lots. Replacement kits will be provided at free of charge. The increased rate of absorbance flags has not been associated with inaccurate results. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |