Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:27037
Brand Name:Atellica CH Ethyl Alcohol (ETOH)
Model:
Affected:All lot numbers
Software version:
Recalling Organisation:Siemens Healthcare (NZ) Ltd
Millennium Centre, Part Level 2, Building A
600 Great South Road
Ellerslie
AUCKLAND 1051
Contact Information:0800 310 300
Manufacturer:Siemens Healthcare Diagnostics Inc
Issue:The manufacturer has confirmed that the Atellica CH ETOH assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. When a positive bias is observed, the magnitude is similar for both quality control and patient results. The product issue potentially affects all Atellica CH ETOH reagent lots.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:11/1/2021
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