Urgent Field Safety Notice For Atellica Ch Enzymatic Hemoglobin A1c (a1c_e) By Siemens Healthcare Diagnostics Inc. Tarrytown

Summary Siemens Healthcare Diagnostics is issuing an urgent safety notice for its Atellica CH Enzymatic Hemoglobin A1c test used to measure blood sugar control in diabetic patients. The notice affects medical facilities in Germany and the EU that use this diagnostic device. The company has classified this as a Class I safety issue, which is the most serious category.

Recalling firm
Siemens Healthcare Diagnostics Inc. Tarrytown
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
Reason
Urgent Field Safety Notice for Atellica CH Enzymatic Hemoglobin A1c (A1c_E) by Siemens Healthcare Diagnostics Inc. Tarrytown
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-07-27
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/9bed2e1d-c1f0-410c-ab7c-0013f3b55ce7