| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00961-1 |
| Product Name/Description |
Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems
Alkaline Phosphatase ALPAMP
Catalogue Number: 03035814
Lot Number: 327460
Alkaline Phosphatase ALPDEA
Catalogue Number: 03036535
Lot Number: 327465
Alkaline Phosphatase Concentrated ALPA_c
Catalogue Number: 06860450
Lot Number: 327471
ARTG Number: 176331 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
The reagent kit lots listed above 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.
The increased rate of absorbance flags with these lots has not been associated with inaccurate results. If Calibration and Quality Control results are acceptable, reported patient results are acceptable. This risk to health is negligible.
Siemens advises the potential for clinical impact and overall risk to health as a result of this issue is negligible. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to quarantine affected units from use prior to destruction and/or disposal.
This action has been closed-out on 23/03/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |