| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01249-1 |
| Product Name/Description |
BD Vacutainer Heparin Tube. n in vitro diagnostic medical device (IVD)
Catalogue Number: 367885
Lot Number: 5084266
ARTG Number: 176053 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
It has been reported that some tubes may contain an incorrect additive, potassium oxalate, instead of lithium heparin.
The presence of potassium could result in falsely elevated potassium results and erroneous results for other analytes, which could lead to the misdiagnosis of serious illnesses. |
| Recall Action |
Recall |
| Recall Action Instructions |
BD is advising users to immediately discontinue the use of the affected units and quarantine any remaining affected stock and return for credit. This action has been closed-out on 02/05/2017. |
| Contact Information |
1800 656 100 - BD Customer Service Department |