R&D Systems — Class II medical device recall Z-2887-2016
Terminated recall by R & D Systems, Inc., reported 2016-10-05, distributed in CA, CO, KY, LA, MA, MD, NJ, OH…. R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿
| Recall number | Z-2887-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | R & D Systems, Inc., Minneapolis, MN, United States |
| Recall initiated | 2016-08-24 |
| Classified | 2016-09-26 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2017-07-26 |
| Distributed | CA, CO, KY, LA, MA, MD, NJ, OH, RI, UT, VA, WA |
| Countries outside the US | AU, CN, GB, ID, IL, IN, JP, KR, MX |
| Model numbers | DTFR1 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2887-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.