FDAFDA · Food and drugs·Recall number Z-0176-2018
Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
Published December 6, 2017 · Recall initiated: May 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- 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
- 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).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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