Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test syst...

FDA Device Recall #Z-1255-2021 — Class II — January 20, 2021

Recall Summary

Recall Number Z-1255-2021
Classification Class II — Moderate risk
Date Initiated January 20, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm R & D Systems, Inc.
Location Minneapolis, MN
Product Type Devices
Quantity 156 kits

Product Description

Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.

Reason for Recall

R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.

Distribution Pattern

USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,

Lot / Code Information

Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604

Other Recalls from R & D Systems, Inc.

Recall # Classification Product Date
Z-0999-2023 Class III R&D CBC-3D Hematology Control: (1) CBC-3D No... Nov 7, 2022
Z-1390-2022 Class III Quantikine IVD Erythropoietin Human Serum Contr... Jun 14, 2022
Z-0691-2019 Class III Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay ... Nov 1, 2018
Z-0410-2019 Class III R&D systems, a bio-techne brand Human Total 25-... Sep 11, 2018
Z-2887-2016 Class II R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay K... Aug 24, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.