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U.S. Department of Health and Human Services

Class 2 Device Recall N PROT CONTROL SL/L, SL/M, SL/H

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  Class 2 Device Recall N PROT CONTROL SL/L, SL/M, SL/H see related information
Date Initiated by Firm June 05, 2017
Create Date November 30, 2017
Recall Status1 Terminated 3 on April 07, 2020
Recall Number Z-0191-2018
Recall Event ID 77515
510(K)Number K052788  
Product Classification Immunochemical, ceruloplasmin - Product Code CHN
Product SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
Code Information SMN 10446079: Lot (UDI): 084647A (00842768016127084647A20170913), 084647C (00842768016127084647C20170913) exp. date 2017-09-13; 084648(0084276801612708464820180430),  084648C (00842768016127084648C20180430),  084648H (00842768016127084648H20180430), exp. date 2018-04-30. --- SMN 10446085: Lot (UDI): 084749D (00842768016134084749D20170917) exp. date 2017-09-17; 084750 (03 0084276801613408475020180203),  084750B (00842768016134084750B20180203), 084750E (00842768016134084750E20180203) exp. date 2018-02-03. --- SMN 10446089: Lot (UDI) 084847A (00842768016110084847A20170613),  084847B (00842768016110084847B20170613) exp. date 2017-06-13; 084848A (00842768016110084848A20171217),  084848D (00842768016110084848D20171217),  084848E (00842768016110084848E20171217),  084848H (00842768016110084848H20171217),  084848L (00842768016110084848L20171217) exp. date 2017-12-17;  084849 (0084276801611008484920180704),  084849C (00842768016110084849C20180704), 084849D (00842768016110084849D20180704) 084849E (00842768016110084849E20180704) exp. date 2018-07-04.
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 2		 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 and Original Applicant = DADE BEHRING, INC.
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