Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21070 |
| Brand Name: | Roche Elecsys Anti HAV |
| Model: | |
| Affected: | Cat No. 04854977190 Elecsys Anti HAV |
| 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 procedure for comparing plasma with serum specimens has changed since the launch of the Elecsys Anti HAV assay in 2001. When a new plasma-to-serum comparison analysis was performed according to the latest protocol, the specifications regarding recovery of the analyte could not be fulfilled for some plasma types. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/2/2017 |
