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U.S. Department of Health and Human Services

Class 3 Device Recall Quantikine IVD Human sTfR Immunoassay

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  Class 3 Device Recall Quantikine IVD Human sTfR Immunoassay see related information
Date Initiated by Firm November 01, 2018
Create Date January 03, 2019
Recall Status1 Terminated 3 on November 03, 2020
Recall Number Z-0691-2019
Recall Event ID 81550
510(K)Number K970718  
Product Classification Immunochemical, transferrin - Product Code JNM
Product Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit.

Product Usage:
The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
Code Information Catalog number DTFR1, Lot number P180851
Recalling Firm/
R & D Systems, Inc.
614 McKinley Pl NE
Minneapolis MN 55413-2610
Manufacturer Reason
for Recall
The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
FDA Determined
Cause 2
Labeling mix-ups
Action R&D Systems, Inc. notified partners on about 11/01/2018 via email. Instructions to Partners included to quarantine and destroy all affected kits on hand, complete and return the Medical Device Recall Return Response form by 11/19/2018, and update and send to customers if further distributed the provided customer letter and Partner Medical Device Recall Return Response form. Both must be sent to each affected partner's customer. Add customer-specific information to the editable Partner Customer Medical Device Recall Return form (replace highlighted text) and include your office email. On your Company stationary, prepare a cover letter for this (1) Recall Notification Customer Letter and (2) partner customer Medical Device Recall Return Response form. Should you mail a hard copy of the letter and Medical Device Recall Return Response Form, address the return envelopes to your office. Additionally partners were instructed to follow up to ensure each affected customer returns a response form, and send all completed returned response form to techserv@bio-techne.com.
Quantity in Commerce 198 kits
Distribution US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to 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.