Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19212 |
| Brand Name: | Roche PreciControl ClinChem Multi 1 |
| Model: | PCCC1 |
| Affected: | 174787 & 174794 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Brand Name: | Roche PreciControl ClinChem Multi 2 |
| Model: | PCCC2 |
| Affected: | 174801 |
| 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: | Roche has received a number of complaints that the recovery of C-Reactive Protein Gen. 3 (CRPL3) was too high in PreciControl ClinChem Multi 1 (PCCC1), and especially in PreciControl ClinChem Multi 2 (PCCC2), seen mainly on the cobas c 501 module. Roche Diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. To resolve this issue a revised target value assignment procedure was necessary. Target values for currently available PCCC1 and PCCC2 control lots have been adjusted as per the tables given in the Customer Letter. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/10/2015 |
