Atellica Ch Enzymatic Hemoglobin A1c (a1c_e)

Recalling firm
Siemens Healthcare (NZ) Ltd
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). [Device]. Affected: Material number - 11097536 / All lots
Reason
The manufacturer has identified a potential issue where Atellica CH Enzymatic Hemoglobin A1c results may be depressed when the Atellica CH Revised C-Reactive Protein assay is run on the same analyzer.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-02-25
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/515204f8-8573-4551-88bd-4625d17118fb