FDA Device recall Z-0181-2022
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
- FDA Device
- Class II
- ongoing
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class II recall of Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 by Siemens Healthcare Diagnostics, citing the firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. False….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0181-2022 |
| 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
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Reason
The firm has confirmed the potential for ADVIA Chemistry 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-0181-2022%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.