Device Recall PROT 1 CON H

  • Model / Serial
    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).
  • Product Classification
  • 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 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
  • Manufacturer
  • 1 Event

Manufacturer

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