Z-0175-2018Class II

Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code...

Name: Z-0175-2018 Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2017-05-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-05-23 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD on 2017-05-23. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0175-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-23
Posted: 2017-11-28
Terminated: 2018-03-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
Product code: CHN Immunochemical, Ceruloplasmin
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).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued an Urgent Medical Device Correction (UMDC) letter (PP-17-012.A.US, dated May 23, 2017) to US customers on May 23, 2017 and an Urgent Field Safety Notice (UFSN) to customers Outside the US in May 2017. Customers were instructed in the letter to use re-assigned CER values for the lots indicated of PROT1 CAL and PROT1 CON L, M, and H. In the US, the method of distribution is FEDEX and outside the US, the distribution is determined at the country level. Customers were requested to complete Effectiveness Check questionnaire attached to the UMDC/UFSN and return to Siemens within 30 days.
Distribution: 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
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0175-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0173-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28
Z-0174-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28
Z-0175-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28
Z-0176-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28

Product code CHN

K083463Class IIDimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1 Control MSiemens Healthcare Diagnostics / cleared 2009-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)