FDA Device recall Z-1255-2021
Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system))
- FDA Device
- Class II
- terminated
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class II recall of Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)) by R And D Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1255-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-20 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | R And D Systems |
| Distribution | CA, FL, LA, OH |
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
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.
Identifiers
| code_info | Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1255-2021%22
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