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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:

Catalog Number: PAK12
Kit Lot Number: 101911P12

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