BN ProSpec® System 10465217Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00630414002736), received between Feb 15, 2018 and Aug 14, 2023 — classified as 23 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K001647); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2023Low Test Results; Low Test Results

  A FALSELY DEPRESSED N LATEX CYSTATIN C (N CYSC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. ON THE FOLLOWING DAY, THE SAMPLE WAS REPROCESSED ON THE ORIGINAL INSTRUMENT TWICE. THE REPEAT RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY DEPRESSED N CYSC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539626 ↗
• MalfunctionAug 26, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT, FALSELY ELEVATED ALBUMIN (SERUM) RESULT AND A DISCORDANT, FALSELY LOW ALBUMIN (CEREBROSPINAL FLUID (CSF)) RESULT WERE OBTAINED ON A SERUM SAMPLE AND A CSF SAMPLE FROM THE SAME PATIENT RUN ON A BN PROSPEC SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY THE SERUM AND THE CSF SAMPLE WERE REPEATED FOR ALBUMIN. THE ALBUMIN (SERUM) RESULT RECOVERED LOWER AND THE ALBUMIN (CSF) RESULT RECOVERED HIGHER. THE REPEAT 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 DISCORDANT ALBUMIN (SERUM) AND ALBUMIN (CSF) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302583 ↗
• MalfunctionMay 27, 2022Smoking; Smoking

  AFTER THE CUSTOMER TURNED ON THEIR BN PROSPEC SYSTEM, THE SYSTEM MADE A BANGING NOISE, AFTER WHICH SMOKE WAS EMITTED FROM THE SYSTEM AND VAPOR FILLED THE ROOM. THE SYSTEM WAS POWERED DOWN AND WAS TAKEN OUT OF OPERATION. THE SYSTEM WAS DOWN FOR ONE DAY AND THERE WAS A DELAY IN PATIENT TESTING OF ONE DAY. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523926 ↗
• MalfunctionAug 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THREE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS WERE OBTAINED ON A PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE RUN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING LOWER. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYPROPYLENE TUBE ON THE SAME BN PROSPEC SYSTEM USING A NEW LOT OF N ANTISERUM TO ALBUMIN REAGENT, RECOVERING FALSELY LOW. THE SAMPLE WAS THEN REPEATED TWO ADDITIONAL TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING HIGHER. THE RESULTS OBTAINED IN THE POLYSTYRENE TUBE WERE CONSIDERED CORRECT. TWO DISCORDANT, FALSELY LOW ALBUMIN RESULTS AND ONE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULT WERE OBTAINED ON A SECOND PATIENT CSF SAMPLE RUN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED THREE TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333306 ↗
• MalfunctionAug 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THREE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS WERE OBTAINED ON A PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE RUN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING LOWER. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYPROPYLENE TUBE ON THE SAME BN PROSPEC SYSTEM USING A NEW LOT OF N ANTISERUM TO ALBUMIN REAGENT, RECOVERING FALSELY LOW. THE SAMPLE WAS THEN REPEATED TWO ADDITIONAL TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING HIGHER. THE RESULTS OBTAINED IN THE POLYSTYRENE TUBE WERE CONSIDERED CORRECT. TWO DISCORDANT, FALSELY LOW ALBUMIN RESULTS AND ONE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULT WERE OBTAINED ON A SECOND PATIENT CSF SAMPLE RUN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED THREE TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333300 ↗
• MalfunctionAug 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THREE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS WERE OBTAINED ON A PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE RUN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING LOWER. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR ALBUMIN CSF IN A POLYPROPYLENE TUBE ON THE SAME BN PROSPEC SYSTEM USING A NEW LOT OF N ANTISERUM TO ALBUMIN REAGENT, RECOVERING FALSELY LOW. THE SAMPLE WAS THEN REPEATED TWO ADDITIONAL TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING HIGHER. THE RESULTS OBTAINED IN THE POLYSTYRENE TUBE WERE CONSIDERED CORRECT. TWO DISCORDANT, FALSELY LOW ALBUMIN RESULTS AND ONE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULT WERE OBTAINED ON A SECOND PATIENT CSF SAMPLE RUN IN A POLYPROPYLENE TUBE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO ALBUMIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED THREE TIMES FOR ALBUMIN CSF IN A POLYSTYRENE TUBE ON THE SAME SYSTEM WITH THE SAME REAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333299 ↗
• MalfunctionJul 30, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM USING N LATEX FLC LAMBDA REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE ELECTROPHORESIS FOR THE AFFECTED SAMPLE SHOWED A HIGHER RESULT, SO THE SAMPLE WAS RERUN TWO TIMES FOR FLC LAMBDA ON THE BN PROSPEC SYSTEM THREE DAYS LATER, ONCE USING A 1:100 AND ONCE USING A 1:400 DILUTION, RECOVERING HIGHER. THE RESULT OBTAINED USING THE 1:400 DILUTION WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THREE DAYS LATER, THE SAMPLE WAS RERUN FOUR MORE TIMES FOR FLC LAMBDA ON AN ATELLICA NEPH 630 SYSTEM, ONCE USING 1:20 DILUTION, ONCE USING A 1:100 DILUTION, AND TWICE USING A 1:400 DILUTION, ALSO RECOVERING HIGHER AND MATCHING THE HIGHER REPEAT RESULT OBTAINED ON THE BN PROSPEC SYSTEM. A NEW SAMPLE FROM THE SAME PATIENT WAS RUN THREE TIMES FOR FLC LAMBDA ON THE ATELLICA NEPH 630 SYSTEM, ONCE USING 1:20 DILUTION, ONCE USING A 1:100 DILUTION, AND ONCE USING A 1:400 DILUTION, MATCHING THE HIGHER RESULTS FROM THE PREVIOUS SAMPLE. NONE OF THE RESULTS FROM THE ATELLICA NEPH 630 SYSTEM WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252028 ↗
• MalfunctionNov 13, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW ALBUMIN RESULT WAS OBTAINED ON A PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO HUMAN ALBUMIN REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S), AS IT DID NOT MATCH THE PATIENT'S TOTAL PROTEIN RESULT. THE SAME SAMPLE WAS REPEATED TWICE FOR ALBUMIN CSF, RECOVERING HIGHER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). TWO DAYS LATER, THE SAME SAMPLE WAS REPEATED AGAIN FOR ALBUMIN CSF, RECOVERING HIGHER AND CONFIRMING THE REPEAT RESULTS FROM TWO DAYS PRIOR. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ALBUMIN CSF RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10838477 ↗
• MalfunctionApr 3, 2020Low Test Results; Low Test Results

  FIVE DISCORDANT, FALSELY DEPRESSED FREE LIGHT CHAINS (FLC) TYPE KAPPA RESULTS AND FOUR DISCORDANT, FALSELY DEPRESSED FLC TYPE LAMBDA RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A BN PROSPEC SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). FOUR DAYS LATER, THE SAMPLES WERE RERUN FOR FLC TYPE KAPPA AND FLC TYPE LAMBDA ON THE SAME BN PROSPEC SYSTEM, RESULTING HIGHER. THESE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FIVE DISCORDANT, FALSELY DEPRESSED FLC TYPE KAPPA RESULTS AND FOUR DISCORDANT, FALSELY DEPRESSED FLC TYPE LAMBDA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9922652 ↗
• MalfunctionMar 7, 2019High Test Results; High Test Results

  THE ELEVATED FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULT OBTAINED ON THE BN PROSPEC SYSTEM WAS REPORTED TO THE PHYSICIAN(S).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8399215 ↗
• MalfunctionMar 7, 2019High Test Results; High Test Results

  THE ELEVATED FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULT OBTAINED ON THE BN PROSPEC SYSTEM WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS ALSO TESTED FOR FLC LAMBDA ON A NON-SIEMENS SYSTEM, RESULTING LOWER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8399214 ↗
• MalfunctionMar 7, 2019High Test Results; High Test Results

  THE ELEVATED FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULT OBTAINED ON THE BN PROSPEC SYSTEM WAS REPORTED TO THE PHYSICIAN(S).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8399213 ↗
• MalfunctionMar 7, 2019High Test Results; High Test Results

  AN ELEVATED FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S) AND IT IS UNKNOWN IF THE SAMPLE WAS REPEATED. THE CUSTOMER REPORTED THAT WHEN SAMPLES FROM THIS PATIENT WERE TESTED USING A NON-SIEMENS METHODOLOGY, THE FLC LAMBDA RESULTS RECOVERED WITHIN NORMAL RANGES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED FLC LAMBDA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8399209 ↗
• MalfunctionFeb 12, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS ALSO TESTED FOR FLC LAMBDA USING A NON-SIEMENS METHOD AND THE CUSTOMER REPORTED THAT A NEGATIVE FLC LAMBDA RESULT WAS OBTAINED USING THE NON-SIEMENS METHOD. THE CUSTOMER REPORTED THE NEGATIVE FLC LAMBDA RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FLC LAMBDA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331431 ↗
• MalfunctionFeb 12, 2019High Test Results; High Test Results

  AN ELEVATED FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S) AND IT IS UNKNOWN IF THE SAMPLE WAS REPEATED. THE CUSTOMER REPORTED THAT THE PATIENT'S IMMUNOGLOBULIN A (KAPPA) M COMPONENT WAS INCREASING AND THAT THE PATIENT'S BONE MARROW WAS COLLECTED THE WEEK PRIOR TO (B)(6) 2019; THE CUSTOMER REPORTED THAT THERE WAS PRESENCE OF KAPPA POSITIVE PLASMA CELLS IN THE PATIENT'S BONE MARROW. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED FLC LAMBDA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331430 ↗
• MalfunctionJan 11, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS ALSO TESTED FOR FLC LAMBDA USING A NON-SIEMENS METHOD, AND A LOWER RESULT WAS OBTAINED ON THE SAMPLE. ON (B)(6) 2018, THE SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING IN ANOTHER DISCORDANT, FALSELY ELEVATED FLC LAMBDA RESULT. THE DISCORDANT RESULTS WERE NOT CORRECTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FLC LAMBDA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8239685 ↗
• MalfunctionJan 11, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS ALSO TESTED FOR FLC LAMBDA USING A NON-SIEMENS METHOD, AND A LOWER RESULT WAS OBTAINED ON THE SAMPLE. ON (B)(6) 2018, THE SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING IN ANOTHER DISCORDANT, FALSELY ELEVATED FLC LAMBDA RESULT. THE DISCORDANT RESULTS WERE NOT CORRECTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FLC LAMBDA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8239659 ↗
• MalfunctionJul 20, 2018Mechanical Problem; Mechanical Problem

  A DISCORDANT, FALSELY ELEVATED ALBUMIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWICE ON THE SAME SYSTEM, RESULTING LOWER. THE LOWEST RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7705849 ↗
• MalfunctionApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE BN PROSPEC SYSTEM USING THE N LATEX FLC LAMBDA REAGENT. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE SAMPLE WAS ALSO RERUN ON THE SAME SYSTEM USING A HIGHER DILUTION (TO EXCLUDE A DOSE HOOK EFFECT) AND A RESULT OF <9.94 MG/L WAS OBTAINED. THE SAMPLE WAS RERUN ON THE SAME SYSTEM, USING A NON-SIEMENS METHOD, RESULTING HIGHER. THE 3RD REPEAT RESULT WAS REPORTED AS THE EXPECTED RESULT TO THE PHYSICIAN(S). ADDITIONALLY, DIFFERENT FREE LIGHT CHAINS (FLC), TYPE KAPPA (FLC KAPPA) RESULTS WERE OBTAINED ON THE SAME SAMPLE BETWEEN THE NON-SIEMENS METHOD AND THE N LATEX FLC KAPPA REAGENT ON THE SAME SYSTEM. THE 2ND REPEAT FLC KAPPA MEASUREMENT WAS RUN TO EXCLUDE A HIGH DOSE HOOK EFFECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC LAMBDA RESULTS AND DIFFERENT FLC KAPPA RESULTS OBTAINED ON THE PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7397596 ↗
• MalfunctionApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE BN PROSPEC SYSTEM USING THE N LATEX FLC LAMBDA REAGENT. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY AND IT IS UNKNOWN WHETHER THIS RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC LAMBDA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7397585 ↗
• MalfunctionApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE BN PROSPEC SYSTEM USING THE N LATEX FLC LAMBDA REAGENT. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE SAMPLE WAS ALSO RERUN ON THE SAME SYSTEM USING A HIGHER DILUTION (TO EXCLUDE A DOSE HOOK EFFECT) AND A RESULT OF <9.94 MG/L WAS OBTAINED. THE SAMPLE WAS RERUN ON THE SAME SYSTEM, USING A NON-SIEMENS METHOD, RESULTING HIGHER. THE 3RD REPEAT RESULT WAS REPORTED AS THE EXPECTED RESULT TO THE PHYSICIAN(S). ADDITIONALLY, DIFFERENT FREE LIGHT CHAINS (FLC), TYPE KAPPA (FLC KAPPA) RESULTS WERE OBTAINED ON THE SAME SAMPLE BETWEEN THE NON-SIEMENS METHOD AND THE N LATEX FLC KAPPA REAGENT ON THE SAME SYSTEM. THE 2ND REPEAT FLC KAPPA RESULT WAS RUN TO EXCLUDE A HIGH DOSE HOOK EFFECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC LAMBDA RESULTS AND DIFFERENT FLC KAPPA RESULTS OBTAINED ON THE PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7397584 ↗
• MalfunctionApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DIFFERENT FREE LIGHT CHAINS (FLC), TYPE LAMBDA (FLC LAMBDA) AND FLC, TYPE KAPPA (FLC KAPPA) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE BN PROSPEC SYSTEM USING THE SIEMENS' N LATEX FLC LAMBDA AND N LATEX FLC KAPPA REAGENTS COMPARED TO AN ALTERNATE NON-SIEMENS REAGENT. THE PATIENT STARTED CHEMOTHERAPY FOR MYELOMA IN (B)(6) 2018 AND IT IS UNKNOWN WHETHER ANY OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT FLC KAPPA AND FLC LAMBDA RESULTS OBTAINED ON THE PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7397582 ↗
• MalfunctionFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW IMMUNOGLOBULIN G (IGG), IMMUNOGLOBULIN A (IGA), IMMUNOGLOBULIN M (IGM), AND BOUND AND FREE LAMBDA TYPE OF HUMAN IMMUNOGLOBULIN LIGHT CHAINS (IG/L CHAIN, TYPE LAMBDA) RESULTS WERE OBTAINED ON A PATIENT SERUM SAMPLE ON THE BN PROSPEC SYSTEM. THE SAMPLE WAS ALSO TESTED FOR BOUND AND FREE KAPPA TYPE OF HUMAN IMMUNOGLOBULIN LIGHT CHAINS (IG/L CHAIN, TYPE KAPPA), RESULTING WITHIN EXPECTED RANGES. ALL THESE RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE DISCORDANT, FALSELY LOW RESULTS. THE SAME SAMPLE WAS RERUN FOR IGG, IG/L CHAIN, TYPE LAMBDA, AND IG/L CHAIN, TYPE KAPPA ON THE SAME SYSTEM. OTHER LOW DISCORDANT RESULTS WERE OBTAINED FOR IGG AND IG/L CHAIN, TYPE LAMBDA. UPON REPEAT, DISCORDANT, FALSELY LOW IG/L CHAIN, TYPE KAPPA RESULTS WERE OBTAINED AT 1:20 DILUTION ON THE PATIENT SAMPLE. ON (B)(6) 2018, THE SAME PATIENT SAMPLE WAS RETESTED FOR ALL PARAMETERS, EXCEPT IG/L CHAIN, TYPE KAPPA, ON THE SAME SYSTEM, RESULTING HIGHER THAN THE INITIAL RESULTS. THESE RESULTS WERE MORE PLAUSIBLE FOR THIS PATIENT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY L

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7275386 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001647. One submission often covers many models, so check the product and lot details in each record.

• Z-2341-2019 · Jun 27, 2019 · Terminated
  N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539