Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0176-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.

Product Classification:

Class II

Date Initiated: May 23, 2017

Date Posted: December 6, 2017

Recall Number: Z-0176-2018

Event ID: 77381

Reason for Recall:

Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).

Status: Terminated

Product Quantity: N/A

Code Information:

Lot numbers: 6EQH01, 6EQH01A, 6EQH01B, 6EQH01C (exp. date 2017-09-17); 6LQH01A, 6LQH01B, 6LQH01C (exp. date 2018-04-04). --- Lot # (UDI): 6EQH01 (008427680063576EQH0120170917), 6EQH01A (008427680063576EQH01A2017091), 6EQH01B(008427680063576EQH01B20170917), 6EQH01C(008427680063576EQH01C20170917), 6LQH01A (008427680063576LQH01A20180404), 6LQH01B (008427680063576LQH01B20180404), 6LQH01C (008427680063576LQH01C20180404).

Distribution Pattern:

Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South

Voluntary or Mandated:

Voluntary: Firm initiated