Device 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.
Z-2887-2016
Product summary
- Event
- Event 75016
- Status
- Terminated
- Classification
- Class II
- Quantity
- 725 kits (502 US, 223 OUS)
- Official record key
device-enforcement:Z-2887-2016
Official wording
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.
Code information: 331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.