Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18119 |
| Brand Name: | Roche Elecsys CMV IgM, diluent universal |
| Model: | Order codes: 04784618190, 03183971122, 11732277122 |
| Affected: | Lots: (04784618190) 179689; (03183971122) 175913, 178383, 178386; (11732277122) 176099, 176899 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | Internal investigations demonstrate that some lots of Diluent Universal may have an influence on the CMV IgM results and may lead to low or false negative results with specific lots of the the Elecsys CMV IgM assay. A certain lot of a specific component used in the Diluent Universal caused the signal reduction of an internal control sample in the Elecsys CMV IgM assay. This internal control sample showed a high reactivity against one specific antigen included in the CMV IgM assay. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/2/2015 |
