R & D Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1255-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.

Product Classification:

Class II

Date Initiated: January 20, 2021

Date Posted: March 24, 2021

Recall Number: Z-1255-2021

Event ID: 87223

Reason for Recall:

R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.

Status: Terminated

Product Quantity: 156 kits

Code Information:

Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604

Distribution Pattern:

USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,

Voluntary or Mandated:

Voluntary: Firm initiated