FDA recall Z-1255-2021

R & D Systems, Inc. · Class II · device

Product

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.

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-01-20
Report date
2021-03-24
Termination date
2023-02-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1255-2021