FDA Enforcement
Class III
Terminated
Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
Recall: Z-0691-2019
·
Reported January 9, 2019
Enforcement
- Recall Number
- Z-0691-2019
- Event ID
- 81550
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- R & D Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 9, 2019
- Initiation Date
- November 1, 2018
- Classification Date
- January 3, 2019
- Termination Date
- November 3, 2020
- Address
- 614 McKinley Pl NE, N/A, Minneapolis, MN, 55413-2610, United States
Description
Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
Reason
The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
Code Info
Catalog number DTFR1, Lot number P180851
Distribution
US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom.
Quantity
198 kits