| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01252-1 |
| Product Name/Description |
VerifyNow Aspirin Test Kit
Item Number: ACD85053
Lot Number : WH0204
ARTG Number: 215577
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
A limited number of kits may result in excessive sample leakage out of the test device cartridge. If this occurs, the VerifyNow performance results are not affected as the leakage occurs "downstream" of where the reaction occurs and operators are protected by the universal precautions for blood products; however, the instrument can potentially be affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
In Vitro Technologies is advising users to inspect stock and quarantine affected batches for return and replacement with unaffected stock.
In Vitro Technologies is advising users to perform a EQC test. This action has been closed-out on 04/05/2017. |
| Contact Information |
1300 552 003 - In Vitro Diagnostics |