Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0175-2018)

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 M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD

Product Classification:

Class II

Date Initiated: May 23, 2017

Date Posted: December 6, 2017

Recall Number: Z-0175-2018

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: 6BQM01, 6BQM01A, 6BQM01B, 6BQM01C,6BQM01D, 6BQM01E (exp. date 2017-06-17); 6FQM01, 6FQM01A (exp. date 2017-11-03) --- Lot # (UDI): 6BQM01 (008427680063336JQL01C20180131), 6BQM01A (008427680063406BQM01A20170617), 6BQM01B (008427680063406BQM01B20170617), 6BQM01C (008427680063406BQM01C20170617), 6BQM01D( 008427680063406BQM01D20170617), 6BQM01E (008427680063406BQM01E20170617), 6FQM01(008427680063406FQM0120171103), 6FQM01A (008427680063406FQM01A20171103).

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