FDA Device recall Z-0180-2022
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
- FDA Device
- Class II
- ongoing
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class II recall of Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 by Siemens Healthcare Diagnostics, citing the firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0180-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-20 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Reason
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Identifiers
| code_info | All lots impacted |
|---|
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-0180-2022%22
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