OFFICIAL-SOURCE RECALL · AUSTRALIA
GS1-HT Extraction Script for use within EasyScreen Sample Processing Recall: Classification Class II Reason
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- GS1-HT Extraction Script for use within EasyScreen Sample Processing Kit Workflow. An in vitro diagnostic medical device (IVD).
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Why this product was recalled
Classification Class II Reason for the Action The impacted extraction scripts contain a missing section of error-handling code for sample positions 81–95. If a low-volume or missing-sample condition occurs in positions 81 - 95, the script may apply recovery logic intended for positions 1 - 80. This can cause the liquid handler to move to preceding specimen positions and aspirate material from an incorrect tube into the corresponding deep-well plate. To date, no adverse events have been reported due to this problem. Instructions for Customers/Users Customers are to: • Follow the interim measures outlined in the Customer Letter for continued use of the product prior to installation of the correction. • Genetic Signatures has amended the extraction-script error-handling logic for sample positions 81–95. • Authorised personnel will install the corrected script and verify and record the installed version before the systems are returned to routine use. • No EasyScreen Sample Processing Kit reagents or consumables need to be quarantined or returned because the physical kit components are not affected. Action Commencement Date 3/08/2026 Responsible Entity Genetic Signatures Ltd
Hazard
Classification Class II Reason for the Action The impacted extraction scripts contain a missing section of error-handling code for sample positions 81–95. If a low-volume or missing-sample condition occurs in positions 81 - 95, the script may apply recovery logic intended for positions 1 - 80. This can cause the liquid handler to move to preceding specimen positions and aspirate material from an incorrect tube into the corresponding deep-well plate. To date, no adverse events have been reported due to this problem. Instructions for Customers/Users Customers are to: • Follow the interim measures outlined in the Customer Letter for continued use of the product prior to installation of the correction. • Genetic Signatures has amended the extraction-script error-handling logic for sample positions 81–95. • Authorised personnel will install the corrected script and verify and record the installed version before the systems are returned to routine use. • No EasyScreen Sample Processing Kit reagents or consumables need to be quarantined or returned because the physical kit components are not affected. Action Commencement Date 3/08/2026 Responsible Entity Genetic Signatures Ltd
Official recall notice
GS1-HT Extraction Script for use within EasyScreen Sample Processing Kit Workflow. An in vitro diagnostic medical device (IVD).
Agency: Therapeutic Goods Administration
Official publication date: August 3, 2026
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