Recall Z-0691-2019 ยท JNM Immunochemical, Transferrin
R & D Systems, Inc.
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.
| Date | Nov 1, 2018 |
| Status | Terminated |
| Reason | The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4. |
| Root cause | Labeling mix-ups |
| Action | R&D Systems, Inc. notified partners on about 11/01/2018 via email. Instructions to Partners included to quarantine and destroy all affected kits on hand, complete and return the Medical Device Recall Return Response form by 11/19/2018, and update and send to customers if further distributed the provided customer letter and Partner Medical Device Recall Return Response form. Both must be sent to each affected partner's customer. Add customer-specific information to the editable Partner Customer Medical Device Recall Return form (replace highlighted text) and include your office email. On your |
| Quantity | 198 kits |
| Distribution | US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970718 | QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) R&D Systems, Inc., May 27, 1997 |