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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00181-1
Product Name/Description	Calibration Serum Level 3. An in vitro diagnostic medical device (IVD). Catalog Number: CAL2351 GTIN: 05055273200966 Batch Numbers: 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE Expiry Dates: 28 Nov 2024, 28 Jan 2025, 28 Sep 2025, 28 Jun 2025, 28 Jan 2025, 28 May 2025, 28 Sep 2025, 28 Sep 2025 ARTG 204567 (Randox Australia Pty Ltd - Multiple clinical chemistry constituent IVDs)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/03/2024
Responsible Entity	Randox Australia Pty Ltd
Reason/Issue	Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351, is running with a negative bias on RX Series instruments compared to other methods. Randox have reassigned the target values in the affected lot numbers in line with the internal master calibrator lot. Users may experience a shift in Quality Control and patient sample recovery up to 7%.
Recall Action	Product Defect Correction
Recall Action Instructions	Please discard all copies of the calibrator IFU and download the updated IFUs from www.randox.com
Contact Information	02 9615 4640 - Randox