Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:29652
Brand Name:Atellica CH Iron_2
Model:Siemens Material Number (SMN) 11097601
Affected:All lots
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 the potential for Atellica CH Iron_2 reagent carryover to impact Microalbumin_2 (µALB_2) results. Falsely elevated µALB_2 results are observed when the assay is processed immediately following an Iron_2 test on the Atellica CH analyser (See Table 2). This issue can impact µALB_2 results for quality control (QC), patient samples and calibrators.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:8/7/2022
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