Recall Z-2703-2026 · PDJ Hemoglobin A1c Test System
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
| Date | Jul 8, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthineers notified consignees on about 06/08/2026 via letter. Consignees were instructed to perform QC on each reagent well used for all A1c_E/A1c_H testing and enable "QC on Pack Change By Assay Type" to ensure QC is performed whenever testing transitions between wells. Enabling this setting will apply QC on Pack Change for all CH assays. If the lab uses Atellica CH to monitor QC, enable Patient QC Flagging to allow identification of potentially impacted patient results following a QC failure. Potentially impacted patient results will display a QC Fail flag and must be held f |
| Quantity | 24,077 units |
| 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, Estonia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay Siemens Healthcare Diagnostics, Inc., Jul 2, 2021 |