FDA Device recall Z-0930-2022
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
- FDA Device
- Class II
- ongoing
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0930-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-09 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Reason
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Identifiers
| code_info | UDI: 00630414595580; Lot Numbers: 211359 211451 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0930-2022%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.