Class II — R & D Systems, Inc.
| Recalling firm | R & D SYSTEMS, INC. |
|---|---|
| Registered facility | R & D SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | R&D Systems, Quantikine® IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1. |
| Quantity | 725 kits (502 US, 223 OUS) |
| Distribution | 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. |
| Initiated | 2016-08-24 |
| Classified | 2016-09-26 |
| Terminated | 2017-07-26 |
| Recall number | Z-2887-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — R & D Systems, Inc. (Z-2887-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75016/
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