Z-0173-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2017
- Initiation Date
- May 23, 2017
- Termination Date
- March 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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
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).
Distribution Pattern
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
Code Information
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).