FDA recall Z-2341-2019

Siemens Healthcare Diagnostics, Inc. · Class II · device

Product

N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539

Reason for recall

Iincreased (falsely elevated) Albumin results compared to expected results

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2019-06-27
Report date: 2019-08-28
Termination date: 2020-05-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2341-2019