Freelite® Human Lambda Free Kit for use on the SPAPLUS – Bulk Kit LK018.10SRecalls & reported problems
The Binding Site Group Limited · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Oct 15, 2021Class IITerminated
Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
Z-0274-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Lambda, Antigen, Antiserum, Control devices
- Freelite® Human Lambda Free Kit for use on the SPAPLUS LK018.SThe Binding Site Group Limited · Lambda, Antigen, Antiserum, Control1 recall2 reports
- Optilite Freelite Lambda Kit LK018.OPT.AThe Binding Site Group Limited · Lambda, Antigen, Antiserum, Control2 reports
- N LATEX FLC lambda 10873630Siemens Healthcare Diagnostics Products GmbH · LAMBDA, ANTIGEN, ANTISERUM, CONTROL1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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