| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00170-1 |
| Product Name/Description |
Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. An in vitro diagnostic medical device (IVD).
Lot 547311 (Cat. no. B4219-1 / SMN 10445713)
Lot 547312 (Cat. no. B4219-2 / SMN 10445714)
Lot 547316 (Cat. no. B4219-2J / SMN 10465681)
Lot 547316A (Cat. no. B4219-2 / SMN 10445714)
Lot 547316AA (Cat. no. B4219-2J / SMN 10465681)
ARTG Number: 178501 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
During recent investigations, Siemens Healthcare Diagnostics has observed that the affected lot numbers show an increase in Heparin sensitivity over the shelf life, prolonging activated partial pro thromboplastin times (APTT). This issue is demonstrated by testing with Dade® Citrol® Heparin Control, low and high. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting customers to discontinue the use of the affected lots and discard any remaining inventory of the affected lots. A look back of previously reported Dade Actin FSL APTT results is at the discretion of the laboratory. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |