Atellica CH Ethyl Alcohol — Class II medical device recall Z-1599-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-04-01, distributed nationwide. The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
| Recall number | Z-1599-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2020-02-14 |
| Classified | 2020-03-26 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2024-02-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BS, CA, CH, CL, CO, CW, CZ, DE, DK, ES, FI, FR, GB, IL, IN, IT, JP, KE, KR, LV, MX, NL, NO, PL, PT, SE, SK, TR, TW, UY, VN |
| Quantity | 1,124 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414596112 |
| Lot numbers | 190133, 190222 |
Product
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Reason for recall
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
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-1599-2020. 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.