FDA Medical Device Recalls (openFDA)
R & D Systems, Inc.: 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.
- Recall number
- Z-0691-2019
- Recalling firm
- R & D Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-11-01
- Posted
- not on file
- Terminated
- 2020-11-03
- Reason
- The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
- Root 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
- 198 kits
- Distribution
- US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom.
- Lot, serial or model codes
- Catalog number DTFR1, Lot number P180851
- 510(k) numbers
- ["K970718"]
- PMA numbers
- not on file
- Product code
- JNM
- Firm FEI
- 2182501
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28