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U.S. Department of Health and Human Services

Class 2 Device Recall Quantikine IVD Human sTfR Immunoassay

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  Class 2 Device Recall Quantikine IVD Human sTfR Immunoassay see related information
Date Initiated by Firm August 24, 2016
Date Posted September 26, 2016
Recall Status1 Terminated 3 on July 26, 2017
Recall Number Z-2887-2016
Recall Event ID 75016
510(K)Number K970718  
Product Classification Immunochemical, Transferrin - Product Code JNM
Product R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
Code Information 331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362. 
Recalling Firm/
Manufacturer		 R & D Systems, Inc.
614 McKinley Pl NE
Minneapolis MN 55413-2610
For Additional Information Contact Bio-Techne's Technical Service
612-379-2956
Manufacturer Reason
for Recall		 R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent via US mail on 8/24/2016 a R&D systems "Urgent Medical Device Recall" letter dated August 23, 2016. The letter described the problem and the product involved in the recall. Advised consignees to stop using the kits and to discard all unused kits and complete and return the enclosed Acknowledgement and Receipt Form. For questions contact Bio-Technes Technical Service Department at 1-612-379-2956 or techserv@bio-techne.com.
Quantity in Commerce 725 kits (502 US, 223 OUS)
Distribution US: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA. OUS: AUSTRALIA, China, INDIA, INDONESIA, ISRAEL, JAPAN, MEXICO, SOUTH KOREA, UNITED KINGDOM.
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 = JNM and Original Applicant = R & D SYSTEMS, INC.
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