Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27574 |
| Brand Name: | Xpert BCR-ABL |
| Model: | |
| Affected: | batch (100242591, GXBCRABL-10 |
| Software version: | |
| Recalling Organisation: | Cepheid AB Rotgenv 2 Solna 17127 Sweden |
| Contact Information: | |
| Manufacturer: | Cepheid AB |
| Issue: | The manufacturer has discovered that batch (100242591, GXBCRABL-10) of Xpert® BCR-ABL Ultra are reporting erroneous results that can in some cases be as much as 1000-fold higher than the true measured values. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/4/2021 |
