| TGA Action ID |
RC-2026-RN-00581-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
GS1-HT Extraction Script for use within EasyScreen Sample Processing Kit Workflow. An in vitro diagnostic medical device (IVD).
Multiple Computer Names
Multiple Computer Serial Numbers
Script Versions: SP012M_ERS_v1.0.0, SP012HT_ERS_v1.7.8 |
| ARTG Number |
224568 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| 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 |
|
| Contact Information |
+353 877734444 - Genetic Signatures Ltd |