Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21692 |
| Brand Name: | Microgenics Application Sheets |
| Model: | |
| Affected: | Various Microgenics Appliction Sheets, All Lots |
| Software version: | |
| Recalling Organisation: | Beckman Coulter NZ Ltd Suite 2, Level 4 30 St Benedicts Street Newton AUCKLAND |
| Contact Information: | 0800 446 109 |
| Manufacturer: | Microgenics Corporation |
| Issue: | During an internal assessment the manufacturer found that Application Sheets provided by Microgenics for expanded use of some Assays are inadequate. Specifically, the appropriate validation data for the expanded use of these Assays, as indicated in the Instructions for Use, when not used on Manufacturer approved analyzers, is inadequate. In addition Microgenics did not clearly state in these Application Sheets that the parameters provided are only to be used as starting points and that each Assay setting needs to be validated individually by the user. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/7/2017 |
