| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00135-1 |
| Product Name/Description |
Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (an in vitro diagnostic medical device (IVD))
Oxoid Legionella Latex Test (DR0800M)
Lot Numbers: 1314413 and 1301907
Oxoid Legionella Pneumophila Serogroup 2-14 Test Reagent (DR0802M)
Lot Number: 1265362 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Investigations by the manufacturer have confirmed that DR0802 Oxoid Legionella Penumophila 2-14 Reagent, Lot 1265366 may return false negative tests. Continued use of this lot may result in a delay to the correct serogroup characterisation of Legionella isolates. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher Scientific is advising users to inspect stock and remove all affected lots from use. Thermo Fisher is advising that the requirement for review of patient results should be determined by the Laboratory Director. |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific Regulatory & Technical Manager |