Optilite Freelite Kappa Kit LK016.OPT.ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05051700017794), received between Nov 18, 2025 and Mar 11, 2026 — classified as 2 injuries, 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026High Test Results

  THE CUSTOMER RELEASED A DISCREPANT, FALSELY ELEVATED KAPPA FREE LIGHT CHAIN (FLC) RESULT (1262.39 MG/L; REF RANGE: 3.30-19.40 MG/L) OBTAINED USING THE FREELITE® ASSAY. THE PATIENT HAD A PRIOR DIAGNOSIS OF AL AMYLOIDOSIS AND WAS UNDER ROUTINE MONITORING. THE ELEVATED RESULT (TAKEN (B)(6) 2026) WAS INCONSISTENT WITH THE PATIENT'S CLINICAL HISTORY AND FOLLOW UP TESTING. A NEW SAMPLE, TAKEN ON (B)(6) 2026, GAVE A KAPPA RESULT OF 11.47 MG/L, CONSISTENT WITH HISTORICAL PATIENT RESULTS. THE CUSTOMER CONFIRMED THAT PATIENT TREATMENT WAS NOT AFFECTED. THE INVESTIGATION DETERMINED THAT QUALITY CONTROL WERE WITHIN RANGE, AND NO ANALYSER OR ASSAY MALFUNCTION WAS IDENTIFIED. ALTHOUGH THERE HAVE BEEN NO REPORTS OF SERIOUS HARM OR INAPPROPRIATE THERAPY, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION. IF THE ERROR WERE TO RECUR, THERE IS A POSSIBILITY OF SERIOUS INJURY IF SAMPLE RESULTS WERE CONSIDERED IN ISOLATION. AS PER THE IFU (INS016.OPT.A), RESULTS OF THE FREE LIGHT CHAIN MEASUREMENTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH OTHER LABORATORY AND CLINICAL FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574421 ↗
• MalfunctionMar 10, 2026High Test Results

  THE CUSTOMER RELEASED A DISCREPANT, FALSELY ELEVATED KAPPA FREE LIGHT CHAIN (FLC) RESULT (1262.39 MG/L; REF RANGE: 3.30-19.40 MG/L) OBTAINED USING THE FREELITE® ASSAY. THE PATIENT HAD A PRIOR DIAGNOSIS OF AL AMYLOIDOSIS AND WAS UNDER ROUTINE MONITORING. THE ELEVATED RESULT (TAKEN (B)(6) 2026) WAS INCONSISTENT WITH THE PATIENT'S CLINICAL HISTORY AND FOLLOW UP TESTING. A NEW SAMPLE, TAKEN ON (B)(6) 2026, GAVE A KAPPA RESULT OF 11.47 MG/L, CONSISTENT WITH HISTORICAL PATIENT RESULTS. THE CUSTOMER CONFIRMED THAT PATIENT TREATMENT WAS NOT AFFECTED. THE INVESTIGATION DETERMINED THAT QUALITY CONTROL WERE WITHIN RANGE, AND NO ANALYSER OR ASSAY MALFUNCTION WAS IDENTIFIED. ALTHOUGH THERE HAVE BEEN NO REPORTS OF SERIOUS HARM OR INAPPROPRIATE THERAPY, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION. IF THE ERROR WERE TO RECUR, THERE IS A POSSIBILITY OF SERIOUS INJURY IF SAMPLE RESULTS WERE CONSIDERED IN ISOLATION. AS PER THE IFU (INS016.OPT.A), RESULTS OF THE FREE LIGHT CHAIN MEASUREMENTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH OTHER LABORATORY AND CLINICAL FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556210 ↗
• InjuryNov 19, 2025Low Test Results; Low Test Results

  A CUSTOMER REPORTED TO THE BINDING SITE AN ERRONEOUSLY LOW KAPPA FREE LIGHT CHAIN (FLC) RESULT (28.3 MG/L; REF RANGE: 3.30 - 19.40 MG/L) OBTAINED USING THE OPTILITE® FREELITE® KAPPA FREE KIT (PRODUCT CODE: LK016.OPT.A), ON (B)(6) 2025. THE RESULT WAS INCONSISTENT WITH EARLIER RESULTS (839.6 & 789 MG/L) FROM SAMPLE DATED (B)(6) 2025 (CONFIRMED BY ERROR REPORT ANALYSIS) AND A STRONGER MONOCLONAL PROTEIN BAND BY SERUM ELECTROPHORESIS. LAMBDA FLC LEVELS WERE CONSISTENTLY LOW AND THE KAPPA/ LAMBDA RATIO WAS ABNORMAL THROUGHOUT. THERE WAS NO ALLEGATION OF SERIOUS INJURY, ALTHOUGH TREATMENT WAS TEMPORARILY PAUSED WHILE THE DISCREPANCY WAS INVESTIGATED. QUALITY CONTROLS (QC) WERE WITHIN RANGE AND ACCEPTABLE THROUGHOUT TESTING. A SUBSEQUENT SAMPLE FROM THE (B)(6) SHOWED AN INCREASE IN KAPPA FLC LEVELS (6426 MG/L). ALTHOUGH THERE HAVE BEEN NO REPORTS OF SERIOUS HARM OR INAPPROPRIATE THERAPY, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION. IF THE ERROR WAS TO RECUR THERE IS A POSSIBILITY OF SERIOUS INJURY IF SAMPLE RESULTS WERE CONSIDERED IN ISOLATION. AS PER THE IFU, INS016.OPT.A, RESULTS OF THE FREE LIGHT CHAIN MEASUREMENTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH OTHER LAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596224 ↗
• MalfunctionNov 18, 2025Low Test Results; Low Test Results

  A CUSTOMER REPORTED TO THE BINDING SITE AN ERRONEOUSLY LOW KAPPA FREE LIGHT CHAIN (FLC) RESULT (28.3 MG/L; REF RANGE: 3.30 - 19.40 MG/L) OBTAINED USING THE OPTILITE® FREELITE® KAPPA FREE KIT (PRODUCT CODE: LK016.OPT.A), ON 22 OCTOBER 2025. THE RESULT WAS INCONSISTENT WITH EARLIER RESULTS (839.6 & 789 MG/L) FROM SAMPLE DATED 17 OCTOBER 2025 (CONFIRMED BY ERROR REPORT ANALYSIS) AND A STRONGER MONOCLONAL PROTEIN BAND BY SERUM ELECTROPHORESIS. LAMBDA FLC LEVELS WERE CONSISTENTLY LOW AND THE KAPPA/ LAMBDA RATIO WAS ABNORMAL THROUGHOUT. THERE WAS NO ALLEGATION OF SERIOUS INJURY, ALTHOUGH TREATMENT WAS TEMPORARILY PAUSED WHILE THE DISCREPANCY WAS INVESTIGATED. QUALITY CONTROLS (QC) WERE WITHIN RANGE AND ACCEPTABLE THROUGHOUT TESTING. A SUBSEQUENT SAMPLE FROM THE 10TH NOVEMBER SHOWED AN INCREASE IN KAPPA FLC LEVELS (6426 MG/L). ALTHOUGH THERE HAVE BEEN NO REPORTS OF SERIOUS HARM OR INAPPROPRIATE THERAPY, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION. IF THE ERROR WAS TO RECUR THERE IS A POSSIBILITY OF SERIOUS INJURY IF SAMPLE RESULTS WERE CONSIDERED IN ISOLATION. AS PER THE IFU, INS016.OPT.A, RESULTS OF THE FREE LIGHT CHAIN MEASUREMENTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582756 ↗

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.