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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00591-1
Product Name/Description LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)

Product Code: TL628921

Lot Number: 10235B

Probes affected: 380, 382, 384, 385

ARTG Number: 217872
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/05/2016
Responsible Entity Diagnostic Solutions Pty Ltd
Reason/Issue It has been determined that the threshold set for HLA-C eRES Probes 380, 382, 384 and 385 in Lot Number 10235B are set high and may result in false negative probe results. The probes resolve the following CWD alleles:

• Probe 380 resolves C*03:06
• Probe 382 resolves C*12:13
• Probe 384 resolves C*01:08
• Probe 385 resolves C*08:06
Recall Action Recall for Product Correction
Recall Action Instructions Diagnostic Solutions is advising users a correction will be made by replacing the old HLA-C eRES MATCHIT! EXP file with a revised MATCHIT! EXP file, which is specific to this single lot. This action has been closed-out on 02/02/2017.
Contact Information 1300 788 003 - Diagnostic Solutions Customer Service