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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00087-1
Product Name/Description	IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medical device (IVD). Reference Number: E-KR-480 Lot Numbers: 013A & 016A ARTG Number: 274979
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/01/2017
Responsible Entity	Abacus ALS Pty Ltd
Reason/Issue	For two lots of the IRT Screening Assay kit (E-KR-480) there is a computer transcription error in the QC sheets for the value of Standard 3, where the value is 50 µg/L instead of 60 µg/L. It has been determined via internal testing that if the cut-off value in use by the laboratory is 90 µg/L or higher, there is no risk of false positive results. For a cut-off value lower than 90 µg/L, the clinical impact depends on the cut-off value fixed by the laboratory/physician. So, depending on the cut-off value used, there may be a risk of a false positive result. As the IRT Screening Assay is a screening test, all positive must be retested using a confirmatory method. Thus, false positive patients will be retested with other tests (DNA etc.) and found negative without harming the health of the patient being a false positive.
Recall Action	Recall for Product Correction
Recall Action Instructions	Abacus ALS is advising users that the correct value of Standard 3 is 50ug/mL (rather than 60ug/mL). The customer letter should be discussed with the Medical Director, with consideration given to the need for a look-back of results previously generated using the affected lots. This action has been closed-out on 01/03/2018.
Contact Information	1800 222 287 - Abacus ALS