Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18387 |
| Brand Name: | Leica Ki67-MM1 Bond RTU |
| Model: | Product Code: PA0118 and KI67-MM1-L-CE |
| Affected: | Lots: 28251, 29784, 29879, 29880, 30673, 30683 (PA0118); and 6031742, 6027899 (KI67-MM1-L-CE) |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd Unit 3, 112-118 Talavera Road North Ryde NSW 2113 Australia |
| Contact Information: | +61 3 9211 7535 |
| Manufacturer: | Leica Biosystems Newcastle Ltd |
| Issue: | Leica Biosystems recently became aware that the affected lots identified do not consistently perform as expected and in some instances have exhibited weaker than expected staining. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/4/2015 |
