FDA Device recall Z-1599-2020
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112 by Siemens Healthcare Diagnostics, citing the assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1599-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-14 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
Identifiers
| code_info | All in-date lots: 190133, 190222 ***Updated 4/6/2020*** New lot added: 100066 ***Updated 9/4/20*** New lot added: 100168 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1599-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.