Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:25460
Brand Name:KIT COBAS 4800 SAMPLE PREP 2 240T CE-IVD
Model:
Affected:Lot - F17079
Software version:
Recalling Organisation:Roche Diagnostics (NZ) Ltd
15 Rakino Way
Mt Wellington
AUCKLAND 1644
Contact Information:0800 363 622
Manufacturer:
Issue:Internal investigation testing on lot F17079 found that it could be the cause for the increase in invalid run controls with the HCV and HIV-1 assays.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:10/12/2019
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