Optilite® Analyser IE700Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05051700020893), received between Nov 27, 2023 and Jan 3, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THIS EVENT DID NOT OCCUR IN THE USA. WE ARE SUBMITTING THIS REPORT BECAUSE THE EVENT OCCURRED AT A HEALTHCARE FACILITY IN THE UNITED KINGDOM, INVOLVING A DEVICE THAT IS ALSO MARKETED IN THE USA. ON 6TH DECEMBER 2024 (THE MANUFACTURER'S DATE OF AWARENESS), A CUSTOMER INFORMED THE BINDING SITE (TBS) THAT THEY OBSERVED RESULTS BEING REPORTED AS DOUBLE WHAT WAS EXPECTED. THE DILUTION FACTOR SENT TO THE OPTILITE WAS "1" INSTEAD OF THE EXPECTED "0" PER THE OPTILITE LIS (LABORATORY INFORMATION SYSTEM) MANUAL (INS700.LIS). AN INITIAL REVIEW BY THE CUSTOMER IDENTIFIED SEVEN IMPACTED SAMPLES DATING BACK TO (B)(6) 2024. FURTHER INVESTIGATIONS REVEALED THAT 146 TEST REQUESTS HAD BEEN IMPACTED SINCE (B)(6) 2024. INVESTIGATIONS CONCLUDED THAT THERE WAS NO MALFUNCTION OF THE OPTILITE ANALYSER INVOLVED IN THE INCIDENT. THE ANALYSER IS WORKING AS EXPECTED. THE ISSUE IS ANTICIPATED TO BE DUE TO AN INCORRECT LIS/MIDDLEWARE REQUEST, WHERE A DILUTION FACTOR OF "1" WAS ADDED INSTEAD OF "0" AS RECOMMENDED IN THE OPTILITE LIS MANUAL. ALTHOUGH NO HARM HAS BEEN REPORTED TO DATE, THE INCIDENT IS BEING REPORTED AS A PRECAUTION DUE TO THE POTENTIAL FOR AN ERRONEOUS TWO-FOLD INCREASE IN RESULTS CAUSED BY INCORR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068423 ↗
• InjuryMay 17, 2024Use of Device Problem; Use of Device Problem

  A CUSTOMER CONTACTED THE BINDING SITE (PDX) ON (B)(6) 2024 TO REPORT THAT ERRONEOUS RESULTS (NO VALUES PROVIDED) ON MULTIPLE ASSAYS RUNNING ON THE BINDING SITE OPTILITE ANALYSER HAD BEEN RELEASED FROM THE LABORATORY TO THE CLINICIAN ON THE (B)(6) 2024. THE CLINICIAN IDENTIFIED THAT CERTAIN SAMPLE RESULTS FOR FREELITE KAPPA FREE KIT (LK016.OPT.A) AND FREELITE LAMBDA FREE KIT (LK018.OPT.A) WERE NOT IN LINE WITH PATIENT CLINICAL HISTORY. THE CUSTOMER REPORTED THAT CLEANING WIPE MATERIAL WAS WRAPPED AROUND THE MIXING PADDLE OF THE OPTILITE ANALYSER. THE MATERIAL WAS REMOVED, SAMPLES WERE RE-RUN AND ALL RESULTS WERE CORRECTED WITHIN THE SAME DAY ((B)(6) 2024). ON THE (B)(6) 2024 (MANUFACTURER DATE OF AWARENESS), THE CUSTOMER PROVIDED VALUES ON AFFECTED SAMPLES FROM THE 17TH OF APRIL. A TOTAL OF 179 RESULTS HAVE BEEN AFFECTED BY THIS ISSUE ACROSS NINE DIFFERENT PDX ASSAYS. THE ASSAYS IMPACTED WERE FREELITE KAPPA FREE KIT (LK016.OPT.A), FREELITE LAMBDA FREE KIT (LK018.OPT.A), BETA-2-MICROGLOBULIN (LK043.OPT.A), OPTILITE® C3C KIT (NK023.OPT.A), OPTILITE® C4 KIT (NK025.OPT.A), OPTILITE® HAPTOGLOBIN KIT (NK058.OPT.A), OPTILITE® IGA KIT (NK010.OPT.A), OPTILITE® IGM KIT (NK012.OPT.A), OPTILITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342333 ↗
• MalfunctionMay 17, 2024Use of Device Problem; Use of Device Problem

  A CUSTOMER CONTACTED THE BINDING SITE (PDX) ON 18TH OF APRIL 2024 TO REPORT THAT ERRONEOUS RESULTS (NO VALUES PROVIDED) ON MULTIPLE ASSAYS RUNNING ON THE BINDING SITE OPTILITE ANALYSER HAD BEEN RELEASED FROM THE LABORATORY TO THE CLINICIAN ON THE (B)(6) 2024. THE CLINICIAN IDENTIFIED THAT CERTAIN SAMPLE RESULTS FOR FREELITE KAPPA FREE KIT (LK016.OPT.A) AND FREELITE LAMBDA FREE KIT (LK018.OPT.A) WERE NOT IN LINE WITH PATIENT CLINICAL HISTORY. THE CUSTOMER REPORTED THAT CLEANING WIPE MATERIAL WAS WRAPPED AROUND THE MIXING PADDLE OF THE OPTILITE ANALYSER. THE MATERIAL WAS REMOVED, SAMPLES WERE RE-RUN AND ALL RESULTS WERE CORRECTED WITHIN THE SAME DAY ((B)(6) 2024). ON THE 25TH OF APRIL 2024 (MANUFACTURER DATE OF AWARENESS), THE CUSTOMER PROVIDED VALUES ON AFFECTED SAMPLES FROM THE (B)(6). A TOTAL OF 179 RESULTS HAVE BEEN AFFECTED BY THIS ISSUE ACROSS NINE DIFFERENT PDX ASSAYS. THE ASSAYS IMPACTED WERE FREELITE KAPPA FREE KIT (LK016.OPT.A), FREELITE LAMBDA FREE KIT (LK018.OPT.A), BETA-2-MICROGLOBULIN (LK043.OPT.A), OPTILITE® C3C KIT (NK023.OPT.A), OPTILITE® C4 KIT (NK025.OPT.A), OPTILITE® HAPTOGLOBIN KIT (NK058.OPT.A), OPTILITE® IGA KIT (NK010.OPT.A), OPTILITE® IGM KIT (NK012.OPT.A), O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339251 ↗
• InjuryDec 5, 2023Use of Device Problem; Use of Device Problem

  ON THE 7TH OF NOVEMBER 2023, WHILE SUPPORTING A CUSTOMER ON A QUERY REGARDING HIGH ACTIVITY "ACTIVITY CHECK (AC)" FLAGS ON THE OPTILITE ANALYZER WHEN RUNNING FREELITE KAPPA FREE KIT (LK016.OPT.A) AND FREELITE LAMBDA FREE KIT (LK018.OPT.A), THE CUSTOMER IDENTIFIED SIX SAMPLE IDS WHERE A LESS THAN'<' FLAG HAD BEEN MANUALLY ACCEPTED. THE CUSTOMER IDENTIFIED THAT EACH RESULT HAD BEEN ALTERED AND RELEASED BY THEIR LIS SOFTWARE AS LOW VALUES OF <0.6 MG/L FREE LIGHT CHAIN (FLC) KAPPA OR <1.5MG/L FLC LAMBDA, WHERE THE ACTUAL RESULT RETURNED BY THE OPTILITE ANALYZER WAS ABNORMALLY HIGH (REFERENCE RANGES STATED IN THE PRODUCT INSTRUCTIONS FOR USE: KAPPA FREE (3.30 -19.40 MG/L) AND LAMBDA FREE (5.71 - 26.30 MG/L)). THE FLC KAPPA/LAMBDA RATIOS REMAINED CORRECTLY ABNORMAL ALBETHEY INVERTED IN 5 OF THE 6 CASES (KAPPA/LAMBDA RATIO NORMAL REF. RANGE: 0.26 - 1.65MG/L). THE CUSTOMER CONFIRMED THAT NO REPORTS OF HARM TO PATIENTS, CHANGE IN PATIENT MANAGEMENT OR INAPPROPRIATE THERAPY HAVE BEEN RECEIVED. ALTHOUGH NO HARM HAS BEEN REPORTED TO DATE AND THE ANALYSER AND ASSAYS ARE PERFORMING AS INTENDED, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION AS IN THREE OF THE SIX CASES, IF THE ERROR WER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268595 ↗
• MalfunctionDec 5, 2023Use of Device Problem; Use of Device Problem

  ON THE 7TH OF NOVEMBER 2023, WHILE SUPPORTING A CUSTOMER ON A QUERY REGARDING HIGH ACTIVITY "ACTIVITY CHECK (AC)" FLAGS ON THE OPTILITE ANALYSER WHEN RUNNING FREELITE KAPPA FREE KIT (LK016.OPT.A) AND FREELITE LAMBDA FREE KIT (LK018.OPT.A), THE CUSTOMER IDENTIFIED SIX SAMPLE IDS WHERE A LESS THAN '<' FLAG HAD BEEN MANUALLY ACCEPTED. THE CUSTOMER IDENTIFIED THAT EACH RESULT HAD BEEN ALTERED AND RELEASED BY THEIR LIS SOFTWARE AS LOW VALUES OF <0.6 MG/L FREE LIGHT CHAIN (FLC) KAPPA OR <1.5MG/L FLC LAMBDA, WHERE THE ACTUAL RESULT RETURNED BY THE OPTILITE ANALYSER WAS ABNORMALLY HIGH (REFERENCE RANGES STATED IN THE PRODUCT INSTRUCTIONS FOR USE: KAPPA FREE (3.30 -19.40 MG/L) AND LAMBDA FREE (5.71 - 26.30 MG/L)). THE FLC KAPPA/LAMBDA RATIOS REMAINED CORRECTLY ABNORMAL ALBETHEY INVERTED IN 5 OF THE 6 CASES (KAPPA/LAMBDA RATIO NORMAL REF. RANGE: 0.26 - 1.65MG/L). THE CUSTOMER CONFIRMED THAT NO REPORTS OF HARM TO PATIENTS, CHANGE IN PATIENT MANAGEMENT OR INAPPROPRIATE THERAPY HAVE BEEN RECEIVED. ALTHOUGH NO HARM HAS BEEN REPORTED TO DATE AND THE ANALYSER AND ASSAYS ARE PERFORMING AS INTENDED, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION AS IN THREE OF THE SIX CASES, IF THE ERROR WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266434 ↗
• MalfunctionNov 27, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THIS EVENT DID NOT OCCUR IN THE USA. WE ARE SUBMITTING THIS REPORT AS THE EVENT OCCURRED AT A HEALTHCARE FACILITY IN THE UNITED KINGDOM ON A DEVICE THAT IS ALSO MARKETED IN THE USA. A CUSTOMER CONTACTED TBS REGARDING DISCREPANT IGG, IGA AND IGM RESULTS OBTAINED ON THE OPTILITE ANALYSER ON THE 30TH OF OCTOBER. THE SAMPLES WERE REPEATED ON THE 1ST OF NOVEMBER 2023 WHERE IT WAS OBSERVED THAT THE INITIAL RESULTS WERE REPORTING AROUND DOUBLE THE CONCENTRATION SEEN ON THE REPEAT TESTING. INVESTIGATIONS CONCLUDED THAT NO MALFUNCTION OF THE OPTILITE ANALYSER HAS BEEN IDENTIFIED AND DISCREPANCY IN THE RESULTS WERE CAUSED BY INCORRECT LABORATORY INFORMATION SYSTEM (LIS) REQUEST. THE CUSTOMER CONFIRMED DISCREPANT RESULTS WERE RELEASED FROM THE LABORATORY WITH CURRENTLY NO REPORTS OF HARM TO PATIENTS, CHANGE IN PATIENT MANAGEMENT OR INAPPROPRIATE THERAPY. ALTHOUGH NO HARM HAS BEEN REPORTED TO DATE, TBS IS REPORTING THIS AS A MATTER OF CAUTION. IF THE MALFUNCTION OF THE LIS SOFTWARE WERE TO RECUR, IT COULD POSSIBLY IMPACT RESULTS ON ANY OPTILITE ASSAY RUN ON THE OPTILITE ANALYSER, WHERE IT MAY CAUSE OR CONTRIBUTE TO SERIOUS INJURY. THE HIGHEST RISK CLASSIFICATION ASSOCIATED WITH ANY TBS OPTILIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208586 ↗