Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20850 |
| Brand Name: | Roche Cobas - Homocysteine Enzymatic Assay |
| Model: | |
| Affected: | Cat No 05385415190 Lot 173114 |
| Software version: | |
| Recalling Organisation: | Roche Consumer Health, Division of Roche Products (NZ) Limited 8 Henderson Place Te Papapa AUCKLAND |
| Contact Information: | |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | Following customer complaints, internal investigations have confirmed under recovery of QC and patient samples with Homocysteine reagent Cat No05385415190 Lot No 173114 by approximately 10-15% after 7 days exposure to 25oC. Correctly stored reagent may show low recovery after 3-4 months. |
| Recall action type: | Correction |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/11/2016 |
