Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21578 |
| Brand Name: | Various Microgenics Application Sheets |
| Model: | |
| Affected: | Incomplete Instructions for Use for Microgenics Application Sheets |
| Software version: | |
| Recalling Organisation: | Thermo Fisher Scientific New Zealand Ltd 244 Bush Road Albany AUCKLAND |
| Contact Information: | 0800 636 327 |
| Manufacturer: | Microgenics Corporation |
| Issue: | During an internal assessment, it was found that certain Application Sheets provided by Thermo Fisher New Zealand for expanded use of some Assays on analyzers that are not listed in the Assay instructions for use are inadequate. Specifically, the validation data included in the Application Sheets for the expanded use of these Assays, is inadequate and will not be included in future Application Sheets. In addition, statements have been added to the Application Sheets that explain that the parameter settings are not supplier qualified and are to be used for instrument programming guidance only, and that each Assay used on a non-Microgenics approved analyzer needs to be validated individually by the user. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/6/2017 |
