Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19682 |
| Brand Name: | Leica Bond Ready- to- Use Primary PAX-5 (1EW) Antibody |
| Model: | PA0552 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | |
| Brand Name: | Leica Bond Ready-to-Use Primary Antibody Alpha-Methylacyl-CoA Racemase |
| Model: | PA0210 |
| Affected: | Al lots |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | |
| Brand Name: | Leica Bond Ready-to-Use ISH CMV Probe |
| Model: | PB0614 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | |
| Brand Name: | Leica Bond Ready-to-Use ISH EBER Probe |
| Model: | PB0589 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | |
| Brand Name: | Leica Bond Ready-to-Use ISH Kappa Probe |
| Model: | PB0645 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | |
| Brand Name: | Leica Bond Ready-to-Use ISH Lambda Probe |
| Model: | PB0669 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | |
| Brand Name: | Leica Bond Ready-to-Use RNA Negative Control Probe |
| Model: | PB0909 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | |
| Brand Name: | Leica Bond Ready-to-Use RNA Positive Control Probe |
| Model: | PB0785 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | |
| Brand Name: | Leica Bond Polymer Refine Detection Kit |
| Model: | DS9800 |
| Affected: | LOts: 42314, 42388, 42474, 42486, 42499, 42555, 42570, 42579, 42627, 42645, 42683, 42780, 42802, 42823, 42852, 43050 |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | |
| Issue: | Manufacturer recently became aware that the product / detection kit combinations identified above may not provide adequate staining when used according to the IFnstructions for Use (IFU). If the products are used according to their IFU with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. The absence of adequate staining of tissue is likely to result in a delay in obtaining the results of IHC / ISH staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm. Bond Polymer Refine detection kits are intended for use with a large numberof other products and the identified kit lots function as specified except when used with the antibody and probe product codes listed in the table above. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/1/2016 |
