Print version of this report

TGA Action ID	RC-2026-RN-00713-1
Type of Product	Medical Device
Product Name/Description	LABScreen Mixed Class I & II. An in vitro diagnostic medical device (IVD). Product code: LSM12 Multiple files names
ARTG Number	387516
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class III
Reason for the Action	The Data Sheets and Catalog Files associated with LABScreen Mixed Class I & II (Cat ID. LSM12, Lot 026) have the incorrect Cell ID and panel typing information for Bead ID 17. The correct information for Bead 17 is Cell ID C4966 (Panel Typing A2, B46, Bw6, Cw1) rather than Cell ID G0223 (Panel Typing A1, A11, B46, B57, Bw6, Bw4, Cw6, Cw8). There is no risk to patient or end user. The performance of the product to qualitatively detect HLA Class I antibody reactivity is not affected.
Instructions for Customers/Users	Customers are to use the updated lot-specific Data Sheets and Catalog files as referenced in the customer letter. Optionally, customers can reanalyse impacted data using the updated Catalog files.
Action Commencement Date	21/09/2026
Responsible Entity	Thermo Fisher Scientific Australia Pty Ltd
Contact Information	1300 735 292 - Thermo Fisher Customer Care Team