| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01065-1 |
| Product Name/Description |
Quantiferon (QFT) Gold Tubes, QFT Gold Unitised Pack, TB Ag Tubes 100ct, QFT Gold Tubes (Nil & TB & Mitogen) High Altitude. An in vitro diagnostic medical device (IVD).
QFT Gold Tubes
Product Number: 0590-0201
Lot Number: 059080251
QFT Gold Unitised Pack
Product Number: T0597-0403
Lot Number: 059780251
TB Ag Tubes 100ct
Product Code: T0592-0201
Lot Number: 059280281
QFT Gold Tubes (Nil & TB & Mitogen) High Altitude (HA)
Product Code: T0590-0505
Lot Number: 059090081 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
Reports of higher than expected rate of Quantiferon (QFT) TB gold positive results from Lot # A111103N have been received; Cellestis initiated an investigation into the situation and confirmed the findings with the identification of 4 positive results from 17 persons who tested negative using several other lots of tubes. Cellestis conducted a review of the manufacturing process and identified the potential contamination of Lot # A111103M (High Altitude) and a portion of tubes from Lot #A111103M.
This recall action was not notified to the TGA before it was initiated by Cellestis Ltd. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is asking all user to discontinue use and dispose of current stock. Customers are advised that is unexpected positive results have been obtained using the affected tubes, results should be considered in light of all clinical information. Patient re-testing using a different Lot of QFT TB-Antigen tubes should be considered. If a re-test is required, Cellestis will provide a replacement. |
| Contact Information |
03 8527 3500 - Cellestis International |