Z-0691-2019Class III

Quantikine IVD ELISA, Human sTfR Immunoassay kit

Name: Z-0691-2019 Quantikine IVD ELISA, Human sTfR Immunoassay kit
Creator: R & D Systems, Inc.
Published: 2018-11-01
License: https://open.fda.gov/license/

R & D Systems, Inc. / initiated 2018-11-01 / Terminated / root cause: labeling and UDI

FDA source

R & D Systems, Inc. began a recall of Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement... on 2018-11-01. FDA classified it as Class III and gives the reason as "The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0691-2019
Classification: Class III
Status: Terminated
Initiated: 2018-11-01
Posted: 2019-01-03
Terminated: 2020-11-03
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.
Product code: JNM Immunochemical, Transferrin
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.
Root cause tag: labeling and UDI
FDA 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 [email protected].
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.
Product codes and lots: Catalog number DTFR1, Lot number P180851

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0691-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0691-2019	Class III	Terminated	Voluntary: Firm initiated	2019-01-09	2019-01-03

Product code JNM

K970718Class IIQuantikine IVD Stfr Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc. / cleared 1997-05-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)