Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17624 |
| Brand Name: | Roche AFB III Staining Kit |
| Model: | |
| Affected: | Lot Numbers: D05755, D11015, E1024 and E03378 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| 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 should recognise the artefacts and reject the slide without attempting to interpret it. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/11/2014 |
