Atellica CH Enzymatic Hemoglobin A1c — Class II medical device recall Z-2703-2026
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2026-07-15, distributed nationwide. The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyze
| Recall number | Z-2703-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2026-06-08 |
| Classified | 2026-07-08 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BG, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GR, HK, HR, ID, IL, IN, IT, JO, JP, KE, KR, KW, LB, LT, LV, MX, MY, NL, NO, NZ, OM, PK, PL, PT, PY, QA, RO, RS, SG, SI, SK, SV, TH, TR, UY, VN, ZA |
| Quantity | 24,077 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414220505 |
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2703-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.