FDA Device recall Z-2451-2023
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determina…
- FDA Device
- Class II
- ongoing
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class II recall of ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determina… by Siemens Healthcare Diagnostics, citing there is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2451-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-25 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
Reason
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.
Identifiers
| code_info | UDI-DI: 00630414279176; Lot Numbers: All lots |
|---|
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-2451-2023%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.