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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00789-3
Product Name/Description	Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. An in vitro diagnostic medical device (IVD) Substrate buffer Lot Number: SB092011 used with: LIFECODES PAK12 Catalog Number: PAK12 Kit Lot Number: 101911P12 LIFECODES PF4IgG Kits Catalog Number: HAT45G Kit Lot Number: 100311H45G
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/08/2012
Responsible Entity	Shanahan Consulting Pty Ltd
Reason/Issue	Anomalous decreases in the average optical density (OD) have been observed with certain kits within the Lifecodes Pak Product Line. The decrease in OD was caused by a chemical reaction with an unknown compound that was introduced into the manufacturing process when faulty vials supplied by a third party were used to contain the substrate buffer kit component.
Recall Action	Recall for Product Correction
Recall Action Instructions	Quarantine and discard affect products. The sponsor recommends reviewing past valid assay runs and compare Positive Control values obtained with recalled kits against historical trend data and discussing results with healthcare providers to determine if any further testing is required.
Contact Information	0419 346 184 - Stephen Shanahan