Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2341-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 27, 2019

Date Posted: August 28, 2019

Recall Number: Z-2341-2019

Event ID: 83311

Reason for Recall:

Iincreased (falsely elevated) Albumin results compared to expected results

Status: Terminated

Product Quantity: 664 units

Code Information:

Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated