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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00174-1
Product Name/Description TREPANOSTIKA TP Recombinant Kit (An in vitro diagnostic medical device (IVD) used for the qualitative determination of specific antibodies to Syphilis (treponema pallidum) in human serum or plasma)

Product Code: 285035

Lot: D33GA

Expiry: 2013-07-28
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 25/02/2013
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue Following customer complaints on out of range negative control, bioMérieux investigation has confirmed an issue with some lots of TREPANOSTIKA™ TP recombinant related to the aluminium bag that contains the microelisa strip plates. The impacted strips may contain bad aluminium bags, or a mixture of
good and bad aluminium bags. As a result, customers may either experience false results or negative control out of range.
Recall Action Recall
Recall Action Instructions Biomereiux is asking customers to stop using the affected lot and discard them.
Contact Information 1800 333 421 - Biomerieux Australia Technical Assistance