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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00702-3
Product Name/Description Premier C. difficile GDH - Positive Control Lot 6088.011, (Enzyme Immunoassay kit for the detection of C. difficile antigen (GDH)); An in vitro diagnostic medical device (IVD)

Catalogue Number: 611096

Lot Number: 611096C013

Expiration Date: 2013-04-28
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 12/07/2012
Responsible Entity Bioline Aust Pty Ltd
Reason/Issue The manufacturer has received reports from customers that the positive Control reagent is producing values close to or below the specified cut off of equal to or greater than 0.600, particularly when using automated instrumentation.
Recall Action Recall for Product Correction
Recall Action Instructions Quarantine and dispose of any remaining affected product appropriately.
Contact Information 02 9209 4763 - Bioline Technical Service