FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
- Recall number
- Z-0174-2018
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
- Status
- Terminated
- Initiated
- 2017-05-23
- Posted
- not on file
- Terminated
- 2018-03-30
- Reason
- 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
- 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.
- Quantity
- not on file
- 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
- Lot, serial or model codes
- Lot numbers: 6BQL01, 6BQL01A, 6BQL01B, 6BQL01C, 6BQL01D (exp. date 2017-06-13); 6JQL01A, 6JQL01B, 6JQL01C (exp. date 2018-01-31). --- Lot # (UDI): 6BQL01 (008427680063336BQL0120170613), 6BQL01A (008427680063406BQM01A20170617), 6BQL01B (008427680063406BQM01B20170617), 6BQL01C (008427680063406BQM01C20170617), 6BQL01D (008427680063406BQM01D20170617), 6JQL01A (008427680063336JQL01A20180131), 6JQL01B (008427680063336JQL01B20180131), 6JQL01C (008427680063336JQL01C20180131).
- 510(k) numbers
- ["K083463"]
- PMA numbers
- not on file
- Product code
- CHN
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28