FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Huma...

FDA Device Recall #Z-2030-2021 — Class II — May 20, 2021

Recall Summary

Recall Number Z-2030-2021
Classification Class II — Moderate risk
Date Initiated May 20, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm The Binding Site Group, Ltd.
Location Birmingham
Product Type Devices

Product Description

FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096

Reason for Recall

The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of CA, GA, FL, MA, MO, MI, WA, NY, PA, MN, AL, MD, OK, NE, IN, ID, OH, TX, HI, DC and the countries of Canada, Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Switzerland, United Kingdom, Argentina, Egypt, GUADELOUPE, HONG KONG, India, Iran, Israel, Korea, Lebanon, Malaysia, Morocco, Oman, Singapore, Taiwan, Tunisia, Vietnam.

Lot / Code Information

Lot Numbers: 487719/ Exp: 31-Jul-2022, 480133/ Exp: 30-Sep-2022, Lot 457890/ Exp: 30-Sep-2022

Other Recalls from The Binding Site Group, Ltd.

Recall # Classification Product Date
Z-0274-2022 Class II Freelite Human Lambda Free Kit (for use on the ... Oct 15, 2021
Z-0943-2021 Class II Optilite Freelite Mx Kappa Free Kit REF LK016.... Nov 18, 2020
Z-2071-2020 Class II The Optilite Clinical Chemistry Analyzer. IVD. ... Apr 9, 2020
Z-1500-2020 Class II Rheumatoid Factor (RF) Kit for use on SPAPLUS, ... Nov 6, 2019
Z-2110-2020 Class II Optilite Optilite Rheumatoid Factor Kit, Ref: ... Oct 7, 2019

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.