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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01034-1
Product Name/Description Quidel Sofia Legionella FIA. An in vitro diagnostic medical device (IVD)

Catalogue Number: QUI20244

Lot Numbers: 100812, 103284, 104721, 109609, 110854, 111447, 217581 and 701553

ARTG Number: 250592
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/10/2015
Responsible Entity Thermo Fisher Scientific Australia Pty Ltd
Reason/Issue Investigations have confirmed that certain lots of Quidel Sofia Legionella FIA may give a false positive reading in some cases some cases due to rheumatoid-like factors present in the urine of some patient specimens. Revised Instructions for Use (IFU) are being provided which specifically references instances where these rheumatoid-like factors may be present and recommends a method for testing these particular patient samples.
Recall Action Recall for Product Correction
Recall Action Instructions Thermo Fisher is providing users with a revised IFU which includes instructions on the treatment of samples when a false positive is suspected.

This action has been closed out on the 17/10/2018.
Contact Information 02 8817 4279 - Thermo Fisher