Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and moni...
FDA Device Recall #Z-1050-2017 — Class II — November 28, 2012
Recall Summary
| Recall Number | Z-1050-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 28, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | The Binding Site Group, Ltd. |
| Location | Birmingham |
| Product Type | Devices |
| Quantity | 1,002 |
Product Description
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Reason for Recall
Calibration curve activity has increased over time in the kit lots listed.
Distribution Pattern
U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.
Lot / Code Information
Lot #323278, 327963
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-2030-2021 | Class II | FREELITE Human Kappa Free Kit for use on the Ro... | May 20, 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 |
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.