Atellica CH Enzymatic Hemoglobin A1c — Class II medical device recall Z-1657-2026
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2026-04-08, distributed nationwide. A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer.
| Recall number | Z-1657-2026 |
|---|---|
| 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 | 2026-02-23 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BG, BR, CA, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, IN, IQ, IT, JO, KR, KW, LT, LV, MX, MY, NL, NO, NZ, OM, PK, PY, QA, RO, RS, SA, SG, SI, SK, TR, UY, ZA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414220505 |
| Lot numbers | 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621 |
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Reason for recall
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
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-1657-2026. 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.