Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01204-1
Product Name/Description	Liquid Specific Protein (LSP) Calibrator. An in vitro diagnostic medical device (IVD) Catalogue Number: 07711199 Lot Number: 303574 Expiry Date: Nov 2015 ARTG: 185171
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	13/11/2014
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	- Siemens has observed an increased frequency of Max Fit Deviation flags using the LSP calibrator kit lot 303574 (vial lots 122IT – 127IT) to calibrate the Alpha-1-Antitrypsin (AAT) assay. The Max Fit Deviation flag impacts the Level 2 calibrator (123IT) for the ADVIA Chemistry Systems Alpha-1-Antitrypsin (AAT) assay. While there is a potential for delay in alpha-1-antitrypsin results due to calibration failures, the risk to health as a result of this issue is negligible. - The LSP calibrator IFU version that resided on the Siemens Document Library from December 10, 2013 until April 7, 2014contained preliminary calibrator values that differed slightly from the final calibrator values for the following ADVIA Chemistry Systems assays: AAG, AAT, ASO_2, C3, C4, FRT, HAPT, IGA_2, IGG_2, IGM_2, PREALB, RF and TRF. The differences between either the final or preliminary calibrator values would not affect the utility of these tests in clinical practice.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is providing laboratories with the correct calibrator values. This action has been closed out on 18/07/2019
Contact Information	1800 310 300 - Siemens Technical Support Centre