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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.

FDA Recall Z-0691-2019 · Posted None

Recalling FirmR & D Systems, Inc.
Recall StatusTerminated
Product CodeJNM
Date Initiated2018-11-01
Date Terminated2020-11-03
Product Quantity198 kits

Reason for Recall

The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.

Firm 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 Company stationary, prepare a cover letter for this (1) Recall Notification Customer Letter and (2) partner customer Medical Device Recall Return Response form. Should you mail a hard copy of the letter and Medical Device Recall Return Response Form, address the return envelopes to your office. Additionally partners were instructed to follow up to ensure each affected customer returns a response form, and send all completed returned response form to [email protected].

Root Cause

Labeling mix-ups

Distribution Pattern

US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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