R & D Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0691-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: November 1, 2018

Date Posted: January 9, 2019

Recall Number: Z-0691-2019

Event ID: 81550

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.

Status: Terminated

Product Quantity: 198 kits

Code Information:

Catalog number DTFR1, Lot number P180851

Distribution Pattern:

US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated