Freelite® Human Lambda Free Kit for use on the SPAPLUS LK018.SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05051700006477), received between Feb 20, 2020 and Feb 28, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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

1. 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 ↗

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.

• InjuryFeb 28, 2020Improper or Incorrect Procedure or Method; Low Test Results; Improper or Incorrect Procedure or Method; Low Test Results

  THIS IS A DUPLICATE COPY OF THE MDR FILED BY OUR PARENT COMPANY (THE MANUFACTURER OF THE DEVICE), BINDING SITE GROUP LIMITED, LOCATED IN (B)(4). THIS DUPLICATE COPY OF THE MDR IS BEING FILED DUE TO 803 SUBPART D WHICH ESTABLISHES IMPORTER REPORTING REQUIREMENTS (BINDING SITE INC., USA) AND SUBPART E ESTABLISHES MANUFACTURER REPORTING REQUIREMENTS, ALTHOUGH IT IS FOR THE SAME EVENT, EACH FIRM (IMPORTER AND MANUFACTURER) SHOULD REPORT THE MDR IF IT MEETS THESE REQUIREMENTS. THIS EVENT DID NOT OCCUR IN THE USA. WE ARE SUBMITTING THIS REPORT AS THE EVENT OCCURED AT A HEALTHCARE FACILITY IN (B)(6) ON A DEVICE THAT IS ALSO MARKETED IN THE USA. THE RESULTING COMPLAINT AND INVESTIGATION WERE COORDINATED BETWEEN THE BINDING SITE (B)(4), THE MANUFACTURER OF THE DEVICE, AND THE BINDING SITE (B)(4), THE SPONSOR OF THE DEVICE IN (B)(4). ON (B)(6) 2019 A PATIENT SAMPLE WAS TESTED USING THE BINDING SITE'S FREELITE LAMBDA FREE KIT FOR USE ON THE SPAPLUS, AT A HEALTHCARE FACILITY IN (B)(6). THIS GAVE A FINAL FREE LAMBDA RESULT OF 151 MG/L (95 PERCENTILE REFERENCE INTERVAL: 5.71 - 26.30 MG/L), WITH NO ANTIGEN EXCESS CHECK FLAG. THIS RESULT WAS SUBSEQUENTLY REPORTED TO THE PHYSICIAN. THE PATIENT WAS

  Patient problems: Renal Failure

  MAUDE report 9769714 ↗
• InjuryFeb 20, 2020Improper or Incorrect Procedure or Method; Low Test Results; Improper or Incorrect Procedure or Method; Low Test Results

  THIS EVENT DID NOT OCCUR IN THE USA. WE ARE SUBMITTING THIS REPORT AS THE EVENT OCCURED AT A HEALTHCARE FACILITY IN (B)(6) ON A DEVICE THAT IS ALSO MARKETED IN THE USA. THE RESULTING COMPLAINT AND INVESTIGATION WERE COORDINATED BETWEEN THE BINDING SITE (B)(6), THE MANUFACTURER OF THE DEVICE, AND THE BINDING SITE (B)(6), THE SPONSOR OF THE DEVICE IN (B)(6). ON (B)(6) 2019 A PATIENT SAMPLE WAS TESTED USING THE BINDING SITE'S FREELITE LAMBDA FREE KIT FOR USE ON THE SPAPLUS, AT A HEALTHCARE FACILITY IN (B)(6). THIS GAVE A FINAL FREE LAMBDA RESULT OF 151 MG/L (95 PERCENTILE REFERENCE INTERVAL: 5.71 - 26.30 MG/L), WITH NO ANTIGEN EXCESS CHECK FLAG. THIS RESULT WAS SUBSEQUENTLY REPORTED TO THE PHYSICIAN. THE PATIENT WAS TREATED FOR THEIR MYELOMA. THE PATIENT DEVELOPED ACUTE RENAL FAILURE AND WAS ADMITTED TO THE ICU ON (B)(6) 2020, AND PLACED ON DIALYSIS. A NEW SAMPLE WAS TESTED ON (B)(6) 2020 WHICH GAVE A RESULT OF 27,454 MG/L. SUBSEQUENTLY THE SAMPLE WHICH WAS TESTED AND RETAINED ON (B)(6) 2019 WAS THAWED AND RETESTED, AND A FINAL RESULT OF 17,182 MG/L OBTAINED. THE TREATING PHYSICIAN COMMENTED THAT HAD A FREELITE RESULT OF 17,182 MG/L BEEN REPORTED TO THEM WHEN THE SAMPLE WAS ORIGINALLY

  Patient problems: Renal Failure

  MAUDE report 9732510 ↗