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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-01045-1
Product Name/Description	COPPER (Cu). An in vitro diagnostic medical device (IVD) Batch Number: 592278, 610661, 610669, 629021, 647201, 657944 Manufacturing Date: 25 Mar 22, 7 Oct 22, 29 Aug 22, 24 Mar 23, 3 Oct 23, 29 Aug 22 Expiry Date: 28 Feb 24, 28 Aug 24, 28 Aug 24, 28 Feb 25, 28 Sep 25, 28 Aug 24 ARTG 199616 (Randox Australia Pty Ltd - Clinical chemistry trace element IVDs)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	1/12/2023
Responsible Entity	Randox Australia Pty Ltd
Reason/Issue	Carryover may occur if Copper is run directly after total protein on RX instruments. If carryover persists, avoid running Copper on analysers that run Total Protein. Interference to the Copper assay can lead to an increase in Quality Control and patient results, which may lead to a delay in running patient samples or increased test results.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers should · Review their instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0148) provided by the sponsor. · Update their RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0148) and ensure all operators are aware of the recommendations. · Discuss the contents of this notice with their Medical Director.
Contact Information	02 9615 4640 - Randox (Australia) Pty