Optilite Freelite Lambda Kit LK018.OPT.ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05051700017800), received between Sep 15, 2026 and Sep 16, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “High Test Results” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K150658, K231290); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026High Test Results; Low Test Results

  The Binding Site were informed by the customer on (b)(6) 2026 that a falsely high Lambda Free Light Chain (FLC) and a falsely low Kappa Free Light Chain (FLC) patient results had been generated using the Freelite® Kappa Free Light Chain assay(LK016.OPT.A) and Freelite® Lambda Free Light Chain assay (LK018.OPT.A) on the Optilite® Analyser and released by the laboratory on (b)(6) 2026.The initial results were 2.3 mg/L for Kappa FLC and 19,722 mg/L for Lambda FLC. The discrepancy was identified when the results did not match the patient history. A redraw was tested on (b)(6) 2026 and produced results of 16 mg/L for Kappa FLC and 14.2 mg/L for Lambda FLC.Although no serious injury or change in patient management occurred, the incident is being reported as a precaution as the falsely high Lambda FLC result could potentially lead to serious injury if a similar issue were to recur and the result was considered in isolation. As stated in the IFUs (INS016.OPT.A and INS018.OPT.A), free light chain measurement results should always be interpreted in conjunction with other laboratory and clinical findings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792695 ↗
• InjurySep 15, 2026High Test Results; Low Test Results

  The Binding Site were informed by the customer on (b)(6) 2026 that a falsely high Lambda Free Light Chain (FLC) and a falsely low Kappa Free Light Chain (FLC) patient results had been generated using the Freelite® Kappa Free Light Chain assay (LK016.OPT.A) and Freelite® Lambda Free Light Chain assay (LK018.OPT.A) on the Optilite® Analyser and released by the laboratory on (b)(6) 2026. The initial results were 2.3 mg/L for Kappa FLC and 19,722 mg/L for Lambda FLC. The discrepancy was identified when the results did not match the patient history. A redraw was tested on (b)(6) 2026 and produced results of 16 mg/L for Kappa FLC and 14.2 mg/L for Lambda FLC.Although no serious injury or change in patient management occurred, the incident is being reported as a precaution as the falsely high Lambda FLC result could potentially lead to serious injury if a similar issue were to recur and the result was considered in isolation. As stated in the IFUs (INS016.OPT.A and INS018.OPT.A), free light chain measurement results should always be interpreted in conjunction with other laboratory and clinical findings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772866 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150658, K231290. One submission often covers many models, so check the product and lot details in each record.

• Z-1043-2017 · Jul 5, 2016 · Terminated
  Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.