Class 3 Device Recall Quantikine IVD Human sTfR Immunoassay

• Date Initiated by Firm: November 01, 2018
• Create Date: January 03, 2019
• Recall Status: Terminated 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/ Manufacturer: 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: 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.