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Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Produc
Recalled December 6, 2017 · FDA recall Z-0173-2018 · Siemens Healthcare Diagnostics
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). · FDA Class II
Units
N/A
Sold at
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
Description
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).
Product
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(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →