Events

Recall of Device Recall PROT 1 CAL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77381
  • Event Risk Class
    Class 2
  • Event Number
    Z-0173-2018
  • Event Initiated Date
    2017-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155942
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Immunochemical, ceruloplasmin - Product Code CHN
  • 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).
  • 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.

Device

Device Recall PROT 1 CAL
  • Model / Serial
    Lot numbers: 6JC001, 6JC001C, 6JC001G (exp. date 2018-01-11); 6MC001, 6MC001C (exp. date 2018-04-29); 6CC001A, 6CC001B, 6CC001F (exp. date 2017-07-14); 6FC001A, 6FC001C, 6FC001E (exp. 2017-10-27); --- Lot # (UDI): 6CC001A (008427680244436CC001A20170714),  6CC001B (008427680244436CC001B20170714),  6CC001F (008427680244436CC001F20170714),  6FC001A (008427680244436FC001A20171027),  6FC001C (008427680244436FC001C20171027),  6FC001E (008427680244436FC001E20171027),  6JC001 (008427680244436JC00120180111),  6JC001C (008427680244436JC001C20180111),  6JC001G (008427680244436JC001G20180111),  6MC001 (008427680244436MC00120180429),  6MC001C (008427680244436MC001C20180429).
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA