R & D Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2887-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.

Product Classification:

Class II

Date Initiated: August 24, 2016

Date Posted: October 5, 2016

Recall Number: Z-2887-2016

Event ID: 75016

Reason for Recall:

R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high.

Status: Terminated

Product Quantity: 725 kits (502 US, 223 OUS)

Code Information:

331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.

Distribution Pattern:

US: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA. OUS: AUSTRALIA, China, INDIA, INDONESIA, ISRAEL, JAPAN, MEXICO, SOUTH KOREA, UNITED KINGDOM.

Voluntary or Mandated:

Voluntary: Firm initiated