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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 Becton Dickinson Pty Ltd
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