Retiro De Equipo (Recall) de IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medical device (IVD).

Recall

RC-2017-RN-00087-1

Class II

2017-01-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00087-1

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.

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.