FDA Device recall Z-2703-2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536
- FDA Device
- Class II
- ongoing
- Published 2026-07-15
On 2026-07-15 the FDA classified a Class II recall of Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536 by Siemens Healthcare Diagnostics, citing 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 patie….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2703-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-08 |
| Published | 2026-07-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
Identifiers
| code_info | Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2703-2026%22
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