FDA Device recall Z-2887-2016
R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations…
- FDA Device
- Class II
- terminated
- Published 2016-10-05
On 2016-10-05 the FDA classified a Class II recall of R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations… by R And D Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2887-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-24 |
| Published | 2016-10-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | R And D Systems |
| Distribution | CA, CO, KY, LA, MA, MD, NJ, OH, RI, UT, VA, WA |
Product
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.
Reason
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.
Identifiers
| code_info | 331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2887-2016%22
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