| 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 |
|
| 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 |