Siemens Healthcare Diagnostics, Inc.: Hemoglobin A1c Test System
Siemens is recalling its Atellica CH Enzymatic Hemoglobin A1c test system because the test can occasionally produce inaccurate results that are either too high or too low. This test is used to measure blood sugar control in diabetes patients and is distributed worldwide, including throughout the United States. The recall affects laboratories and healthcare facilities using this specific test kit.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
- Reason
- The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina¿Faso, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Democratic Republic Congo, Denmark, Ecuador, Egypt, El Salvador,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f02ff73d-c162-4d3f-ab9b-6db148321252