CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report
Freelite Human Lambda Free Kit for use on Spaplus Product recalled
The Binding Site Group is recalling Freelite Human Lambda Free Kit for use on Spaplus, distributed nationwide in the US. The recall was initiated on 28 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1053-2017
- FDA event ID
- 76050
- Recalling firm
- The Binding Site Group, Birmingham
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Oct 2016
- FDA classified
- 19 Jan 2017
- Reported
- 25 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 28 Oct 2016 | Recall initiated by company | |
| 19 Jan 2017 | Classified by FDA | +83 days |
| 25 Jan 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A change in the calibration curve causing an increase in false prozone flags.
Product as listed by the FDA
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
Where it was distributed
Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
Questions about this recall
Why was it recalled?
A change in the calibration curve causing an increase in false prozone flags.
Which lots are affected?
Lot #400012, 400257
Where was it sold?
Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Binding Site Group
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Exent Analyser recalled by The Binding Site Group | The Binding Site Group | Potency & Assay | Nationwide |
| Device | CLASS II | Freelite Human Lambda Free Kit (for use on the Spaplus) recalled | The Binding Site Group | Other | 13 states |
| Device | CLASS II | Freelite Human Kappa Free Kit recalled by The Binding Site Group | The Binding Site Group | Other | Nationwide |
| Device | CLASS II | Optilite Freelite Mx Kappa Free Kit recalled by The Binding Site Group | The Binding Site Group | Other | 10 states |
| Device | CLASS II | Optilite Rheumatoid Factor Kit recalled by The Binding Site Group | The Binding Site Group | Other | 20 states |
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| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |