Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20953 |
| Brand Name: | Roche PreciControl Varia |
| Model: | |
| Affected: | PreciControl Varia Lot number: 189285-01, Elecsys PTH Assay Lot numbers: 143251 and 185000 |
| 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: | During routine quality control checks it was observed that the barcode and value sheet of PreciControl Varia lot 189285-01 contain an wrong target value for PTH on Elecsys 2010 cobas e 411, for control level 2. The currently present value of 17.4 pmol/L (164 pg/mL) is incorrect. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Wholesale |
| Date Commenced: | 16/12/2016 |
