| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01161-1 |
| Product Name/Description |
AFB III Staining Kit (An in vitro diagnostic medical device (IVD))
(Qualitative histologic stain to selectively indicate Mycobacterium and other acid fast organisms)
Lot Numbers: D05755, D11015, E1024 and E03378
ARTG Number 174922 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diagnostics has observed a staining artefact on slides stained with the AFB III Staining Kit. This artefact consists of a circular and a non-specific purple- to pink-coloured slide background staining, which in some cases is present within tissue elements and in other cases takes the form of circular deposits that appear to be above the tissue plane. The latter can occur both within the tissue-containing and blank portions of the slide. This artefact may interfere with the interpretation and identification of acid-fast bacteria, which is the indication for this assay. Also, the artefact could be mistaken for acid-fast bacteria and lead to a false positive interpretation. A trained pathologist would recognise the artefacts and reject the slide without attempting to interpret it. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche Diagnostic Australia Pty Ltd is requesting the customers to identify and discard the affected lots and is providing credit for the affected lots that are discarded. Roche Diagnostic is also requesting the customers to consider the need to review patient results using the affected lots. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 645 619 - Roche Diagnostics National Support Centre |