Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24622 |
| Brand Name: | Elecsys Syphilis |
| Model: | Cobas e 411/601/602 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | The manufacturer has identified that erroneous values were stated in the method sheet (version 1.0 and 2.0) of Elecsys Syphilis, 200 test/kit on cobas e 411, cobas e 601 and cobas e 602, section limitations – interference where the potential interference of IgG and IgM is listed. In the column Concentration tested 32 g/dL is written instead of the correct 3.2 g/dL for IgG, and 10 g/dL is written instead of the correct 1.0 g/dL for IgM. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/5/2019 |
