Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Quantikine IVD Human sTfR Immunoassay

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Quantikine IVD Human sTfR Immunoassay see related information
Date Initiated by Firm January 20, 2021
Create Date March 15, 2021
Recall Status1 Terminated 3 on February 13, 2023
Recall Number Z-1255-2021
Recall Event ID 87223
510(K)Number K970718  
Product Classification Immunochemical, transferrin - Product Code JNM
Product Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.
Code Information Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604
Recalling Firm/
Manufacturer		 R & D Systems, Inc.
614 Mckinley Pl Ne
Minneapolis MN 55413-2610
Manufacturer Reason
for Recall		 R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.
FDA Determined
Cause 2		 Under Investigation by firm
Action Users of these kits are requested to stop using these kits for measuring Human sTfR for diagnostic purposes in patient samples and to discard all unused kits or kit components. Customers were instructed to complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form to R&D Systems by February 20, 2021, by emailing the form to techserv@bio-techne.com. For questions regarding this recall, or need to obtain a product credit, contact Bio-Technes Technical Service Department at 1-612-379-2956 or techserv@bio-techne.com.
Quantity in Commerce 156 kits
Distribution USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,
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.
-
-