Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28125 |
| Brand Name: | BOND Ready-to-Use Primary Antibody CDX2 (EP25) |
| Model: | |
| Affected: | Lot number - 69909 |
| Software version: | |
| Recalling Organisation: | Leica Microsystems Pty Ltd, New Zealand Branch 3/33 Spartan Road Takanini Auckland 2105 |
| Contact Information: | 021 0841 7323 |
| Manufacturer: | Leica Biosystems Newcastle Ltd |
| Issue: | The manufacturer recently became aware that the PA0375 BOND Ready-To-Use Primary Antibody CDX2 (EP25) may not perform as specified in the IFU. They have determined that although the product is giving the appropriate nuclear positivity that would be expected, there may also be some staining outside of the product specification in the form of membrane staining not typical of CDX2, including on specimens that do not demonstrate appropriate CDX2 nuclear positivity. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/8/2021 |
