R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble ...

FDA Device Recall #Z-2887-2016 — Class II — August 24, 2016

Recall Summary

Recall Number Z-2887-2016
Classification Class II — Moderate risk
Date Initiated August 24, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm R & D Systems, Inc.
Location Minneapolis, MN
Product Type Devices
Quantity 725 kits (502 US, 223 OUS)

Product 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 for Recall

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.

Distribution Pattern

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.

Lot / Code Information

331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.

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-1255-2021 Class II Quantikine IVD Human sTfR Immunoassay (Human sT... Jan 20, 2021
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

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.