Freelite® Human Kappa Free Kit for use on the Roche cobas® systems LK016.CBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05051700012096), received between Mar 22, 2024 and Mar 28, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

• InjuryMar 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A CUSTOMER CONTACTED THE BINDING SITE (PDX) ON THE 08TH OF FEBRUARY 2024 TO REPORT THAT THEIR PDX FREELITE® HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS® C SYSTEMS ASSAY (PRODUCT CODE: LK016.CB, KIT LOT: 490912) WAS PRODUCING UNUSUALLY HIGH KAPPA RESULTS ON ONE OF THEIR INSTRUMENTS. ON THE 27TH OF FEBRUARY 2024, THE CUSTOMER INFORMED PDX THAT 20 RESULTS RELEASED FROM THE LABORATORY FOR KAPPA FREE WERE FALSELY ELEVATED. 15 OF THESE RESULTS WERE ABOVE THE TOTAL ALLOWABLE ERROR (TEA) OF 40% OF THE ASSAY. THE TESTING TOOK PLACE ON THE 24TH JANUARY 2024, 02ND FEBRUARY 2024 AND 04TH FEBRUARY 2024 TO THE 07TH FEBRUARY 2024 AND THE DISCREPANCY WAS IDENTIFIED BY THE CLINICIAN ON 08TH FEBRUARY 2024. UPON REPEAT TESTING ON AN ADDITIONAL ANALYSER, THE CUSTOMER OBTAINED RESULTS WHICH THEY REPORTED TO BE MORE IN LINE WITH THE CLINICAL PICTURE. THE CUSTOMER REPORTED THAT FOR THE INITIAL INSTRUMENT THE ISSUE WAS RESOLVED FOLLOWING REPLACEMENT OF A SAMPLE PROBE AND A NEW KIT LOT. ALTHOUGH NO REPORTS HAVE BEEN RECEIVED OF HARM TO PATIENTS, CHANGE IN PATIENT MANAGEMENT OR INAPPROPRIATE THERAPY, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION. IF THE ERROR WERE TO RECUR FOR 1 OF THE 15 RELE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993740 ↗
• MalfunctionMar 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A CUSTOMER CONTACTED THE BINDING SITE (PDX) ON THE 08TH OF FEBRUARY 2024 TO REPORT THAT THEIR PDX FREELITE® HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS® C SYSTEMS ASSAY (PRODUCT CODE: LK016.CB, KIT LOT: 490912) WAS PRODUCING UNUSUALLY HIGH KAPPA RESULTS ON ONE OF THEIR INSTRUMENTS. ON THE (B)(6) 2024, THE CUSTOMER INFORMED PDX THAT 20 RESULTS RELEASED FROM THE LABORATORY FOR KAPPA FREE WERE FALSELY ELEVATED. 15 OF THESE RESULTS WERE ABOVE THE TOTAL ALLOWABLE ERROR (TEA) OF 40% OF THE ASSAY. THE TESTING TOOK PLACE ON THE (B)(6) 2024, (B)(6) 2024 AND (B)(6) 2024 TO THE (B)(6) 2024 AND THE DISCREPANCY WAS IDENTIFIED BY THE CLINICIAN ON (B)(6) 2024. UPON REPEAT TESTING ON AN ADDITIONAL ANALYSER, THE CUSTOMER OBTAINED RESULTS WHICH THEY REPORTED TO BE MORE IN LINE WITH THE CLINICAL PICTURE. THE CUSTOMER REPORTED THAT FOR THE INITIAL INSTRUMENT THE ISSUE WAS RESOLVED FOLLOWING REPLACEMENT OF A SAMPLE PROBE AND A NEW KIT LOT. ALTHOUGH NO REPORTS HAVE BEEN RECEIVED OF HARM TO PATIENTS, CHANGE IN PATIENT MANAGEMENT OR INAPPROPRIATE THERAPY, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION. IF THE ERROR WERE TO RECUR FOR 1 OF THE 15 RELEASED DISCREPANT RESULTS ABOVE THE TEA THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959893 ↗