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.
데이터 추가 비고
Immunochemical, ceruloplasmin - Product Code CHN
원인
Siemens healthcare diagnostics has confirmed a negative bias of approximately -20% for results obtained with n antiserum to human ceruloplasmin when calibrating ceruloplasmin with various lots of n protein standard sl. n/t protein controls sl for ceruloplasmin are similarly biased. --- the affected standards and controls for the affected lots were incorrectly value assigned, which led to a lower result compared to correctly assigned standards.
note: n antiserum to human ceruloplasmin (ref ouie) works as intended. --- siemens investigation indicated that n protein standard sl and corresponding n/t protein control sl (levels low, mid and high) are inaccurately assigned for ceruloplasmin.
조치
URGENT MEDICAL DEVICE CORRECTION Letter (PP17-011.a.US, dated May 30, 2017) was sent to US consignees via FedEx on 6/5/2017. URGENT FIELD CORRECTIVE ACTION Letter was e-mailed to customers Outside the US. Customers are instructed to use the re-assigned Ceruloplasmin values for the lots indicated in the letter.
Worldwide including the countries of United States, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Great Britain, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, japan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea (S), Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, South Africa, Switzerland, Syria, Taiwan, Thailand, Trinidad-Tobago, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Vatican, Venezuela,
제품 설명
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073