Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-00844-1 |
Product Name/Description |
BD Affirm VPIII Microbial Identification Tests (used for the testing of multiple infectious organisms). An in vitro diagnostic medical device (IVD)
Catalogue Number: 446252
Lot/Batch Numbers: 5135673, 5138774 Expiry Date: 09/02/2016
ARTG Number: 223745 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
1/09/2015 |
Responsible Entity |
|
Reason/Issue |
A portion of tests associated with the referenced lots/batches may exhibit blue speckles or fibres on the beads and cards. This issue would cause difficulty in interpreting test (control & patient) results across all beads. This would result in an invalid test. |
Recall Action |
Recall |
Recall Action Instructions |
BD is advising users to discontinue use and discard any remaining stock. This action has been closed-out on 17/08/2016. |
Contact Information |
TBC |