FDA Enforcement
Class II
Terminated
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.
Recall: Z-2887-2016
·
Reported October 5, 2016
Enforcement
- Recall Number
- Z-2887-2016
- Event ID
- 75016
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- R & D Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 5, 2016
- Initiation Date
- August 24, 2016
- Classification Date
- September 26, 2016
- Termination Date
- July 26, 2017
- Address
- 614 McKinley Pl NE, N/A, Minneapolis, MN, 55413-2610, United States
Description
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.
Code Info
331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.
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.
Quantity
725 kits (502 US, 223 OUS)