Class 2 Device Recall N PROT STANDARD SL

• Date Initiated by Firm: June 05, 2017
• Create Date: November 30, 2017
• Recall Status: Terminated on April 07, 2020
• Recall Number: Z-0190-2018
• Recall Event ID: 77515
• 510(K)Number: K012470
• Product Classification: Immunochemical, ceruloplasmin - Product Code CHN
• Product: SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
• Code Information: Lot Numbers(UDI): 083611A (00842768007590083611A20170711), 083611B (00842768007590083611B20170711), 083611C (00842768007590083611C20170711), 083611D (00842768007590083611D20170711), exp. date 2017-07-11; 083612 (0084276800759008361220171014), 083612A (00842768007590083612A20171014), 083612B (00842768007590083612B20171014), exp. date 2017-10-14; 083614A (00842768007590083614A20180127), 083614B (00842768007590083614B20180127), 083614C (00842768007590083614C20180127), exp. date 2018-01-27; 083615 (0084276800759008361520180411), 083615A (00842768007590083615A20180411), 083615B (00842768007590083615B20180411), 083615C (00842768007590083615C20180411), exp. date 2018-04-11; 083616B (00842768007590083616B20180730), 083616C (00842768007590083616C20180730), 083616D (00842768007590083616D20180730), exp. date 2018-07-30.
• FEI Number: 3003098680
• Recalling Firm/ Manufacturer: CSL Behring GmbH; Emil-von-Behring-Str. 76; Marburg Germany
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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.
• Distribution: 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,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = CHN