BN II System 11254820Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00630414002903), received between Jul 13, 2020 and Apr 19, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ERRONEOUS PATIENT RESULTS WERE OBTAINED ON A BN II SYSTEM. IT IS UNKNOWN HOW MANY PATIENTS WERE IMPACTED OR WHICH ASSAYS WERE IMPACTED. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143311 ↗
• MalfunctionNov 21, 2023Low Test Results; Low Test Results

  FALSELY LOW FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A BN II SYSTEM USING N LATEX FLC LAMBDA REAGENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR FLC LAMBDA ON AN ALTERNATE BN II SYSTEM, RECOVERING HIGHER. THE CUSTOMER CONTACTED THE PHYSICIAN(S) ABOUT THE EVENT AND REPORTED THE REPEAT RESULTS, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW FLC LAMBDA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185703 ↗
• MalfunctionOct 13, 2023High Test Results; High Test Results

  A FALSELY ELEVATED FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING A 1:100 SAMPLE DILUTION. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWO TIMES FOR FLC KAPPA, ONCE USING A 1:400 DILUTION AND ONCE USING A 1:100 DILUTION, BOTH TIMES RECOVERING LOWER. THE REPEAT RESULT OBTAINED USING THE 1:100 DILUTION WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED FLC KAPPA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930251 ↗
• MalfunctionAug 24, 2023Low Test Results; Low Test Results

  A FALSELY LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWO TIMES FOR FLC KAPPA, RECOVERING HIGHER. THE FIRST REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW FLC KAPPA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17619012 ↗
• MalfunctionMay 18, 2023Low Test Results; Low Test Results

  LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULTS WERE OBTAINED ON FIVE PATIENT SAMPLES AND A LOW FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING N LATEX FLC KAPPA REAGENT AND N LATEX FLC LAMBDA REAGENT. THE SAMPLES WERE ALSO RUN USING IMMUNOFIXATION WHICH SHOWED POSITIVE M-BANDS FOR KAPPA AND LAMBDA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW FLC KAPPA AND FLC LAMBDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956961 ↗
• MalfunctionMay 18, 2023Low Test Results; Low Test Results

  A LOW FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING THE N LATEX FLC LAMBDA REAGENT. IT IS UNKNOWN WHETHER THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS ALSO RUN USING IMMUNOFIXATION, WHICH SHOWED A POSITIVE M-BAND FOR FLC LAMBDA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT FLC LAMBDA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956725 ↗
• MalfunctionOct 27, 2022Low Test Results; Low Test Results

  A FALSELY LOW KAPPA LIGHT CHAINS RESULT WAS OBTAINED ON A PATIENT SAMPLE USING A 1:20 SAMPLE DILUTION ON A BN II SYSTEM USING N ANTISERUM TO HUMAN IG/L-CHAIN, TYPE KAPPA REAGENT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS USING A 1:100 SAMPLE DILUTION, RECOVERING HIGHER. THE HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW KAPPA LIGHT CHAINS RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685745 ↗
• MalfunctionOct 27, 2022Low Test Results; Low Test Results

  TWO FALSELY LOW KAPPA LIGHT CHAINS RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES USING A 1:20 SAMPLE DILUTION ON A BN II SYSTEM USING N ANTISERUM TO HUMAN IG/L-CHAIN, TYPE KAPPA REAGENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR KAPPA LIGHT CHAINS USING A 1:100 SAMPLE DILUTION, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW KAPPA LIGHT CHAINS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685718 ↗
• MalfunctionDec 6, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING N ANTISERUM TO HUMAN IG/L-CHAIN, TYPE KAPPA REAGENT USING A 1:20 SAMPLE DILUTION. THE SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS USING A 1:100 DILUTION, RECOVERING HIGHER. THE SAMPLE WAS THEN REPEATED FOR KAPPA LIGHT CHAINS USING A 1:20 DILUTION, AGAIN RECOVERING FALSELY LOW. NONE OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE HIGHER RESULT OBTAINED USING THE 1:100 DILUTION MATCHED THE ELECTROPHORESIS RESULT FOR THE PATIENT AND WAS CONSIDERED TO BE CORRECT. A DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULT WAS OBTAINED ON ANOTHER SAMPLE FROM A DIFFERENT PATIENT ON THE SAME BN II SYSTEM USING N ANTISERUM TO HUMAN IG/L-CHAIN, TYPE KAPPA REAGENT USING A 1:20 SAMPLE DILUTION. THE SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS USING A 1:100 DILUTION, RECOVERING HIGHER. THE SAMPLE WAS THEN REPEATED FOR KAPPA LIGHT CHAINS USING A 1:20 DILUTION, RECOVERING FALSELY LOW. THE SAMPLE WAS THEN REPEATED FOR KAPPA LIGHT CHAINS USING A 1:400 DILUTION, RECOVERING FALSELY LOW. THE FOLLOWING DAY, THE SAMPLE WAS MANUALLY DILUTED 1:2 AND WAS THEN REPEATED FOR KAPPA LIGHT CHAINS USING A 1:20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12939269 ↗
• MalfunctionApr 16, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE USING A 1:100 DILUTION ON A BN II SYSTEM USING N LATEX FLC KAPPA REAGENT. THE SAMPLE WAS THEN REPEATED TWO MORE TIMES USING A 1:20 DILUTION, ALSO RECOVERING FALSELY LOW. NONE OF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). TWO DAYS LATER, THE SAMPLE WAS REPEATED USING A 1:2000 DILUTION, RECOVERING HIGHER. THIS HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON THE SAME PATIENT SAMPLE ON THE SAME BN II SYSTEM USING N LATEX FLC LAMBDA REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). TWO DAYS LATER, THE SAMPLE WAS REPEATED FOR FLC LAMBDA, RECOVERING HIGHER. THIS HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC KAPPA AND FLC LAMBDA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678835 ↗
• MalfunctionNov 6, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING N LATEX FLC KAPPA REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWO TIMES THE SAME DAY FOR FLC KAPPA USING A 1:400 DILUTION, RECOVERING HIGHER THAN THE INITIAL RESULT. THE SAMPLE WAS THEN REPEATED AGAIN THE SAME DAY FOR FLC KAPPA USING A 1:2000 DILUTION, RECOVERING HIGHER. THE FLC KAPPA RESULT OBTAINED WITH THE 1:2000 DILUTION WAS REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED AGAIN FOR FLC KAPPA AND EXHIBITED THE SAME BEHAVIOR AS THE DAY BEFORE. EIGHT DAYS LATER, THE SAMPLE WAS REPEATED SIX TIMES FOR FLC KAPPA USING A 1:100, 1:400, 1:2000, 1:8000, 1:40000, AND 1:160000 DILUTION, RECOVERING PROGRESSIVELY HIGHER WITH EACH DILUTION. THE RESULT OBTAINED WITH THE 1:160000 DILUTION WAS CONSIDERED CORRECT. NONE OF THE RESULTS OBTAINED ON THIS DAY WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC KAPPA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10803679 ↗
• MalfunctionNov 6, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING N LATEX FLC KAPPA REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWO TIMES THE SAME DAY FOR FLC KAPPA USING A 1:400 DILUTION, RECOVERING HIGHER THAN THE INITIAL RESULT. THE SAMPLE WAS THEN REPEATED AGAIN THE SAME DAY FOR FLC KAPPA USING A 1:2000 DILUTION, RECOVERING HIGHER. THE FLC KAPPA RESULT OBTAINED WITH THE 1:2000 DILUTION WAS REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED AGAIN FOR FLC KAPPA AND EXHIBITED THE SAME BEHAVIOR AS THE DAY BEFORE. EIGHT DAYS LATER, THE SAMPLE WAS REPEATED SIX TIMES FOR FLC KAPPA USING A 1:100, 1:400, 1:2000, 1:8000, 1:40000, AND 1:160000 DILUTION, RECOVERING PROGRESSIVELY HIGHER WITH EACH DILUTION. THE RESULT OBTAINED WITH THE 1:160000 DILUTION WAS CONSIDERED CORRECT. NONE OF THE RESULTS OBTAINED ON THIS DAY WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC KAPPA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10803649 ↗
• MalfunctionNov 6, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING N LATEX FLC KAPPA REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWO TIMES THE SAME DAY FOR FLC KAPPA USING A 1:400 DILUTION, RECOVERING HIGHER THAN THE INITIAL RESULT. THE SAMPLE WAS THEN REPEATED AGAIN THE SAME DAY FOR FLC KAPPA USING A 1:2000 DILUTION, RECOVERING HIGHER. THE FLC KAPPA RESULT OBTAINED WITH THE 1:2000 DILUTION WAS REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED AGAIN FOR FLC KAPPA AND EXHIBITED THE SAME BEHAVIOR AS THE DAY BEFORE. EIGHT DAYS LATER, THE SAMPLE WAS REPEATED SIX TIMES FOR FLC KAPPA USING A 1:100, 1:400, 1:2000, 1:8000, 1:40000, AND 1:160000 DILUTION, RECOVERING PROGRESSIVELY HIGHER WITH EACH DILUTION. THE RESULT OBTAINED WITH THE 1:160000 DILUTION WAS CONSIDERED CORRECT. NONE OF THE RESULTS OBTAINED ON THIS DAY WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC KAPPA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10803623 ↗
• MalfunctionSep 16, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING N ANTISERUM TO HUMAN-IG/L-CHAIN, K-TYPE REAGENT USING A 1:20 SAMPLE DILUTION. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS USING A 1:100 DILUTION ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING HIGHER. THE RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS WITH THE SAME SYSTEM AND REAGENT USING A 1:20 DILUTION, RECOVERING LOWER. THIS RESULT WAS CONSIDERED DISCORDANT. THE SAMPLE WAS THEN REPEATED FOR KAPPA LIGHT CHAINS USING A 1:100 DILUTION ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING HIGHER. THIS RESULT WAS CONSIDERED CORRECT. NEITHER OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10540310 ↗
• MalfunctionSep 16, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING N ANTISERUM TO HUMAN-IG/L-CHAIN, K-TYPE REAGENT USING A 1:20 SAMPLE DILUTION. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS USING A 1:100 DILUTION ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING HIGHER. THE RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS WITH THE SAME SYSTEM AND REAGENT USING A 1:20 DILUTION, RECOVERING LOWER. THIS RESULT WAS CONSIDERED DISCORDANT. THE SAMPLE WAS THEN REPEATED FOR KAPPA LIGHT CHAINS USING A 1:100 DILUTION ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING HIGHER. THIS RESULT WAS CONSIDERED CORRECT. NEITHER OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10540309 ↗
• MalfunctionJul 30, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS (FLC) KAPPA RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A BN II SYSTEM USING N LATEX FLC KAPPA REAGENT. THE SAMPLE WAS REPEATED FOR FLC KAPPA USING THE SAME DILUTION, RECOVERING HIGHER. THE SAMPLE WAS REPEATED AGAIN FOR FLC KAPPA USING A DIFFERENT DILUTION. THE RESULT RECOVERED FALSELY LOW. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR FLC KAPPA, RESULTING HIGHER. THIS REPEAT RESULT WAS CONSIDERED THE CORRECT RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC KAPPA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10347438 ↗
• MalfunctionJul 13, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM USING N ANTISERUM TO IGL CHAIN TYPE KAPPA REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS ON THE SAME SYSTEM USING A 1:100 DILUTION, RESULTING HIGHER. THIS REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10264738 ↗