BCS® XP System 10459330Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00630414945514), received between Sep 29, 2017 and Aug 22, 2024 — classified as 63 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (26 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K970431); 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.

Recalls naming this device

1. Mar 2, 2021Terminated

   Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.

   Z-1435-2021 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Smoking; Smoking

  THE CUSTOMER REPORTED THE OBSERVATION OF A BCS XP SYSTEM (SN#(B)(6)) WHICH WAS NOT IN COMMUNICATION WITH THE CENTRAL PROCESSING UNIT (CPU). DURING TROUBLESHOOTING BY THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE), THE SAMPLE TRANSFER PRINTED CIRCUIT BOARD (PCB) BEGAN TO SMOKE BEFORE BLOWING A FUSE. THE CSE FOUND 4 FUSES WERE BLOWN. NO HARM TO THE USER WAS ALLEGED DUE TO THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED DUE TO THIS EVENT. 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 20032562 ↗
• MalfunctionFeb 10, 2023Low Test Results; Low Test Results

  TWO FALSELY LOW VON WILLEBRAND FACTOR ACTIVITY (VWF AC) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A BCS XP SYSTEM USING BC VON WILLEBRAND REAGENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE FOLLOWING DAY THE SAME SAMPLE WAS REPEATED FOR VWF AC ON AN ALTERNATE BCS XP SYSTEM, 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 VWF AC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358337 ↗
• MalfunctionAug 26, 2022High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND RUN FOR PT AND INR, RECOVERING LOWER. THE LOWER 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 PT AND INR RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302546 ↗
• MalfunctionSep 3, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM (SERIAL NUMBER: (B)(4)) USING ACTIN FSL REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR APTT ON AN ALTERNATE BCS XP SYSTEM (SERIAL NUMBER: (B)(4)), RECOVERING HIGHER. THIS HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE SAMPLE WAS THEN REPEATED ON BCS XP SYSTEM (SERIAL NUMBER: (B)(4)), ALSO RECOVERING HIGHER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421211 ↗
• MalfunctionApr 22, 2021Low Test Results; Low Test Results

  TWO DISCORDANT, FALSELY LOW VON WILLEBRAND FACTOR ACTIVITY (VWF AC) RESULTS AND TWO DISCORDANT, FALSELY LOW VON WILLEBRAND FACTOR ANTIGEN (VWF AG) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM. THE VWF AC RESULTS WERE OBTAINED WITH BC VON-WILLEBRAND REAGENT (LOT 557480). THE VWF AG RESULTS WERE OBTAINED WITH A NON-SIEMENS REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). LATER THE SAME DAY, THE SAMPLE WAS REPEATED TWICE MORE FOR VWF AC AND TWICE MORE FOR VWF AG. THE REPEAT RESULTS RECOVERED HIGHER THAN THE INITIAL LOW RESULTS. THE SAMPLE WAS ALSO RUN FOR FACTOR VIII ON THE SAME DAY. THE FACTOR VIII RESULTS RECOVERED IN THE NORMAL RANGE AND WERE NOT CONSIDERED DISCORDANT. THE FOLLOWING DAY, THE SAMPLE WAS REPEATED TWICE MORE FOR VWF AC AND TWICE MORE FOR VWF AG ON AN ALTERNATE BCS XP SYSTEM. THE REPEAT RESULTS RECOVERED HIGHER AND MATCHED THE REPEAT RESULTS FROM THE PREVIOUS DAY. A CORRECTED REPORT WAS ISSUED, BUT IT IS UNKNOWN WHICH RESULTS WERE INCLUDED IN THE CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW VON WILLEBRAND FACTOR ACTIVITY AND VON WILLEBRAND FACTOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711199 ↗
• MalfunctionApr 12, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW D-DIMER RESULT WAS OBTAINED ON A PATIENT SAMPLE USING THE D-DIMER LOW PROTOCOL ON A BCS XP SYSTEM USING INNOVANCE D-DIMER REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THREE OTHER DOUBTFUL D-DIMER RESULTS WERE OBTAINED ON THIS BCS XP SYSTEM, WHICH WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR D-DIMER USING THE D-DIMER LOW PROTOCOL ON AN ALTERNATE BCS XP SYSTEM, RECOVERING HIGHER. THE SAMPLE WAS REPEATED AGAIN USING THE D-DIMER HIGH PROTOCOL ON THE ALTERNATE BCS XP SYSTEM, ALSO RECOVERING HIGHER. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). A NEW SAMPLE FROM THE SAME PATIENT WAS THEN RUN FOR D-DIMER ON THE SAME ALTERNATE BCS XP SYSTEM USING BOTH THE D-DIMER LOW AND D-DIMER HIGH PROTOCOLS. THE RESULTS MATCHED THE PREVIOUS RESULTS OBTAINED ON THE ALTERNATE BCS XP SYSTEM. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW D-DIMER RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11651585 ↗
• MalfunctionMar 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER CONTACTED SIEMENS REQUESTING INFORMATION ABOUT THE EFFECTS OF EMICIZUMAB CARRYOVER ON THE BCS XP SYSTEM. THE CUSTOMER DID NOT OBTAIN DISCORDANT PATIENT RESULTS DUE TO THIS ISSUE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11531573 ↗
• MalfunctionMar 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER CONTACTED SIEMENS REQUESTING INFORMATION ABOUT THE EFFECTS OF EMICIZUMAB CARRYOVER ON THE BCS XP SYSTEM. THE CUSTOMER DID NOT OBTAIN DISCORDANT PATIENT RESULTS DUE TO THIS ISSUE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11531572 ↗
• MalfunctionMar 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, PROTHROMBIN TIME (PT), PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR), ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), AND D-DIMER RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A BCS XP SYSTEM. SOME OF THE RESULTS WERE FLAGGED WITH "ABSORBANCE TOO HIGH" AND "OPTICAL SYSTEM EXCEEDED THE MEASURING RANGE" ERRORS, BUT THE FLAGGED RESULTS WERE NOT IDENTIFIED. NO DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE DELAY IN PATIENT TESTING WAS MITIGATED AS THE CUSTOMER HAD AN ALTERNATE BCS XP SYSTEM TO PROCESS THE SAMPLES. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS OR THE DELAY IN PATIENT TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426850 ↗
• MalfunctionJan 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ONE DISCORDANT FALSELY ELEVATED AND FOUR DISCORDANT FALSELY LOW HEPARIN RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING A NON-SIEMENS ASSAY. THE SAMPLE WAS ALSO REPEATED ONCE MORE FOR HEPARIN ON THE BCS XP SYSTEM USING INNOVANCE HEPARIN REAGENT, RESULTING FALSELY LOW. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CORRECT HEPARIN RESULT FOR THIS PATIENT WAS REPORTED TO PHYSICIAN(S), BUT IT IS UNKNOWN WHICH SYSTEM AND REAGENT WERE USED TO OBTAIN THE CORRECT RESULT. ONE DISCORDANT FALSELY ELEVATED AND TWO DISCORDANT FALSELY LOW HEPARIN RESULTS WERE ALSO OBTAINED ON A PATIENT SAMPLE FROM A DIFFERENT PATIENT ON THE SAME BCS XP SYSTEM USING A NON-SIEMENS ASSAY. THE SAMPLE WAS REPEATED A FOURTH TIME FOR HEPARIN ON THE BCS XP SYSTEM USING A NON-SIEMENS ASSAY, GENERATING THE CORRECT RESULT WHICH WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS ALSO REPEATED ONCE MORE FOR HEPARIN ON THE BCS XP SYSTEM USING INNOVANCE HEPARIN REAGENT, RESULTING FALSELY LOW. NONE OF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HEPARIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11117949 ↗
• MalfunctionDec 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY ELEVATED AND FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES FROM THE SAME PATIENT MEASURED ON A BCS XP SYSTEM USING ACTIN FSL REAGENT. PRIOR TO BEING RUN ON THE BCS XP SYSTEM, EACH OF THE SAMPLES WAS RUN FOR APTT ON A SYSMEX CS-5100 SYSTEM. NO NUMERICAL RESULTS WERE GENERATED ON THE SYSMEX CS-5100 SYSTEM. WHEN RUN FOR APTT ON THE BCS XP SYSTEM, EACH OF THE SAMPLES GAVE A FALSELY LOW RESULT WITH A "DOUBTFUL FLAG" ON THE FIRST RUN. ON THE SECOND RUN, THE FIRST SAMPLE GAVE A FALSELY LOW APTT RESULT, THE SECOND SAMPLE GAVE A FALSELY ELEVATED APTT RESULT, AND THE THIRD SAMPLE DID NOT GIVE A NUMERICAL RESULT AND GENERATED A "CURVE WITHOUT REACTION" ERROR. ON THE THIRD RUN, THE FIRST SAMPLE GAVE A FALSELY ELEVATED APTT RESULT, THE SECOND SAMPLE GAVE A FALSELY LOW APTT RESULT, AND THE THIRD SAMPLE GAVE A FALSELY LOW APTT RESULT. A FALSELY LOW APTT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. A CORRECTED REPORT WAS ISSUED BUT IT IS UNKNOWN WHICH RESULT WAS REPORTED IN THE CORRECTED REPORT. SEVERAL DAYS LATER, A NEW SAMPLE FROM THE SAME PATIENT WAS MEASURED, RECOVERING ACCEPTABLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003036 ↗
• MalfunctionDec 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY ELEVATED AND FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES FROM THE SAME PATIENT MEASURED ON A BCS XP SYSTEM USING ACTIN FSL REAGENT. PRIOR TO BEING RUN ON THE BCS XP SYSTEM, EACH OF THE SAMPLES WAS RUN FOR APTT ON A SYSMEX CS-5100 SYSTEM. NO NUMERICAL RESULTS WERE GENERATED ON THE SYSMEX CS-5100 SYSTEM. WHEN RUN FOR APTT ON THE BCS XP SYSTEM, EACH OF THE SAMPLES GAVE A FALSELY LOW RESULT WITH A "DOUBTFUL FLAG" ON THE FIRST RUN. ON THE SECOND RUN, THE FIRST SAMPLE GAVE A FALSELY LOW APTT RESULT, THE SECOND SAMPLE GAVE A FALSELY ELEVATED APTT RESULT, AND THE THIRD SAMPLE DID NOT GIVE A NUMERICAL RESULT AND GENERATED A "CURVE WITHOUT REACTION" ERROR. ON THE THIRD RUN, THE FIRST SAMPLE GAVE A FALSELY ELEVATED APTT RESULT, THE SECOND SAMPLE GAVE A FALSELY LOW APTT RESULT, AND THE THIRD SAMPLE GAVE A FALSELY LOW APTT RESULT. A FALSELY LOW APTT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. A CORRECTED REPORT WAS ISSUED BUT IT IS UNKNOWN WHICH RESULT WAS REPORTED IN THE CORRECTED REPORT. SEVERAL DAYS LATER, A NEW SAMPLE FROM THE SAME PATIENT WAS MEASURED, RECOVERING ACCEPTABLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003026 ↗
• MalfunctionDec 11, 2020Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW HEPARIN RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING A NON-SIEMENS ASSAY. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). AFTER RECALIBRATING THE NON-SIEMENS ASSAY, THE SAMPLE WAS REPEATED FOR HEPARIN ON THE SAME BCS XP SYSTEM USING THE SAME NON-SIEMENS REAGENT, RESULTING HIGHER. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE SAMPLE WAS ALSO REPEATED ONE MORE TIME ON THE BCS XP USING INNOVANCE HEPARIN REAGENT, RESULTING HIGHER AND CONFIRMING THE HIGHER RESULT OBTAINED WITH THE NON-SIEMENS REAGENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HEPARIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10993925 ↗
• MalfunctionOct 6, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW D-DIMER RESULT WAS OBTAINED ON A BCS XP SYSTEM USING INNOVANCE D-DIMER REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED FOR D-DIMER TWO TIMES ON AN ALTERNATE BCS XP SYSTEM, ONCE USING THE D-DIMER LOW APPLICATION AND ONCE USING THE D-DIMER HIGH APPLICATION. BOTH RESULTS RECOVERED HIGHER THAN THE INITIAL DISCORDANT RESULT. THE PATIENT WAS REDRAWN AND THE REDRAWN SAMPLE WAS RUN FOR D-DIMER ON THE SAME ALTERNATE BCS XP SYSTEM, ONCE USING THE D-DIMER LOW APPLICATION AND ONCE USING THE D-DIMER HIGH APPLICATION. BOTH RESULTS RECOVERED HIGHER THAN THE INITIAL DISCORDANT RESULT. THE HIGHER REPEAT 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 DISCORDANT, FALSELY LOW D-DIMER RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10635771 ↗
• MalfunctionSep 1, 2020Low Test Results; Low Test Results

  TWO DISCORDANT, FALSELY LOW VON WILLEBRAND FACTOR ACTIVITY (VWF AC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM (SERIAL NUMBER: (B)(4)) WITH BC VON WILLEBRAND REAGENT (LOT 557470). THE PATIENT SAMPLE WAS PREVIOUSLY FROZEN PRIOR TO THE INITIAL DISCORDANT RESULTS BEING OBTAINED. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLE WAS ALSO RUN FOR VON WILLEBRAND FACTOR ANTIGEN (VWF AG) AND FACTOR VIII ON THE SAME DAY. THESE RESULTS WERE ALSO REPORTED TO THE PHYSICIAN(S) AND IT IS UNKNOWN IF THEY WERE CONSIDERED DISCORDANT. THE SAMPLE WAS RE-FROZEN AND WAS RERUN TWICE FOR VWF AC SEVEN DAYS LATER, RECOVERING HIGHER. THESE REPEAT 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 DISCORDANT, FALSELY LOW VON WILLEBRAND FACTOR ACTIVITY (VWF AC) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10478476 ↗
• MalfunctionJun 9, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE OBTAINED FROM AUTOMATIC REPEATS OF PT AND INR AFTER A "NO REACTION" ERROR WAS INITIALLY GENERATED BY THE SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE PATIENT WAS TOLD TO SKIP HIS NEXT COUMADIN DOSE DUE TO THE HIGH RESULTS. A SECOND SAMPLE FROM THE SAME PATIENT WAS RUN LATER THE SAME DAY FOR PT AND INR, RESULTING LOWER. THESE RESULTS WERE ALSO REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, ANOTHER SAMPLE FROM THE SAME PATIENT WAS RUN FOR PT AND INR, RESULTING LOWER. THESE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER THEN REPEATED THE ORIGINAL SAMPLE FROM THE PREVIOUS DAY FOR PT AND INR. A "NO REACTION" ERROR WAS GENERATED AND THE SAMPLE WAS AUTOMATICALLY REPEATED FOR PT AND INR, BOTH RECOVERING FALSELY ELEVATED. THE OTHER SAMPLE FROM THE PREVIOUS DAY WAS ALSO REPEATED FOR PT AND INR, RECOVERING FALSELY ELEVATED AND MATCHING THE RESULTS OBTAINED FOR THIS SAMPLE FROM THE PREVIOUS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10134639 ↗
• MalfunctionJun 9, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE OBTAINED FROM AUTOMATIC REPEATS OF PT AND INR AFTER A "NO REACTION" ERROR WAS INITIALLY GENERATED BY THE SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE PATIENT WAS TOLD TO SKIP HIS NEXT COUMADIN DOSE DUE TO THE HIGH RESULTS. A SECOND SAMPLE FROM THE SAME PATIENT WAS RUN LATER THE SAME DAY FOR PT AND INR, RESULTING LOWER. THESE RESULTS WERE ALSO REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, ANOTHER SAMPLE FROM THE SAME PATIENT WAS RUN FOR PT AND INR, RESULTING LOWER. THESE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER THEN REPEATED THE ORIGINAL SAMPLE FROM THE PREVIOUS DAY FOR PT AND INR. A "NO REACTION" ERROR WAS GENERATED AND THE SAMPLE WAS AUTOMATICALLY REPEATED FOR PT AND INR, BOTH RECOVERING FALSELY ELEVATED. THE OTHER SAMPLE FROM THE PREVIOUS DAY WAS ALSO REPEATED FOR PT AND INR, RECOVERING FALSELY ELEVATED AND MATCHING THE RESULTS OBTAINED FOR THIS SAMPLE FROM THE PREVIOUS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10134634 ↗
• MalfunctionJan 27, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW HEPARIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE REPORTED RESULT AND WAS ADMINISTERED LOW MOLECULAR WEIGHT HEPARIN (LOVENOX). THE NEXT DAY THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED THAT THE SAMPLE BE REPEATED FOR HEPARIN. THE ORIGINAL SAMPLE WAS REPEATED TWICE FOR HEPARIN, RESULTING HIGHER. THESE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE PATIENT BEING ADMINISTERED LOVENOX AS A RESULT OF THE DISCORDANT, FALSELY LOW HEPARIN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9632274 ↗
• MalfunctionNov 5, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER REPORTED THAT WHEN THE UNINTERRUPTABLE POWER SUPPLY (UPS) FOR THEIR BCS XP SYSTEM WAS POWERED ON WITH THE BCS XP SYSTEM CONNECTED, THE UPS SPARKED AND EMITTED A BURNING SMELL. THE CUSTOMER UNPLUGGED THE UPS FROM THE AC OUTLET AND POWERED OFF THE BCS XP SYSTEM. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9278803 ↗
• MalfunctionJun 18, 2019High Test Results; High Test Results

  AFTER FAILING A VALIDATION KIT TEST ON A BCS XP SYSTEM, THE CUSTOMER REPEATED PREVIOUSLY RUN PATIENT SAMPLES AND DETERMINED THAT A DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT USING PATHROMTIN SL REAGENT LOT 536708B ON A BCS XP SYSTEM (SERIAL NUMBER (SN): (B)(4)) WAS REPORTED TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLE WAS REPEATED ON A SECOND BCS XP SYSTEM (SN: (B)(4)) AND RESULTED LOWER. THE CUSTOMER STATED THAT THE PATHOLOGIST REVIEWED THE INITIAL AND REPEAT RESULTS AND CONCLUDED THAT THE OBTAINED RESULTS WERE NOT SIGNIFICANT BECAUSE THE PATIENT HAD SUBSEQUENT LAB WORK DONE EVERY 5 HOURS. THERE ARE NO REPORTS OF PATIENT INTERVENTION NOR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8708760 ↗
• MalfunctionMar 19, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEY'VE USED THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE IN A NON-SIEMENS LABORATORY INFORMATION SYSTEM (LIS) TO CALCULATE INTERNATIONAL NORMALIZED RATIO (INR) RESULTS AFTER THE SAMPLES WERE PROCESSED CORRECTLY ON A BCS XP SYSTEM. THE CUSTOMER USED THE ISI VALUE OF 0.93 TO CALCULATE PATIENT SAMPLES' INR RESULTS INSTEAD OF THE ISI VALUE OF 1.09. THE CUSTOMER INDICATED THAT SINCE (B)(6) 2019, THEY REPORTED PATIENTS' INR RESULTS USING THE INCORRECT ISI VALUE DAILY FOR 3 WEEKS. AS PER THE CUSTOMER, 26 PATIENTS (41 SAMPLES) WERE IMPACTED BY THIS ISSUE. THE CUSTOMER DID NOT IDENTIFY WHICH PATIENTS WERE IMPACTED NOR THE DATES OF TESTING. THE PATIENT'S INR RESULTS WERE RECALCULATED USING THE CORRECT ISI VALUE. THE CORRECT INR RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER USING THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE TO CALCULATE INR RESULTS FOR PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433114 ↗
• MalfunctionMar 19, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEY'VE USED THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE IN A NON-SIEMENS LABORATORY INFORMATION SYSTEM (LIS) TO CALCULATE INTERNATIONAL NORMALIZED RATIO (INR) RESULTS AFTER THE SAMPLES WERE PROCESSED CORRECTLY ON A BCS XP SYSTEM. THE CUSTOMER USED THE ISI VALUE OF 0.93 TO CALCULATE PATIENT SAMPLES' INR RESULTS INSTEAD OF THE ISI VALUE OF 1.09. THE CUSTOMER INDICATED THAT SINCE (B)(6) 2019, THEY REPORTED PATIENTS' INR RESULTS USING THE INCORRECT ISI VALUE DAILY FOR 3 WEEKS. AS PER THE CUSTOMER, 26 PATIENTS (41 SAMPLES) WERE IMPACTED BY THIS ISSUE. THE CUSTOMER DID NOT IDENTIFY WHICH PATIENTS WERE IMPACTED NOR THE DATES OF TESTING. THE PATIENT'S INR RESULTS WERE RECALCULATED USING THE CORRECT ISI VALUE. THE CORRECT INR RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER USING THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE TO CALCULATE INR RESULTS FOR PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433111 ↗
• MalfunctionMar 19, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEY'VE USED THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE IN A NON-SIEMENS LABORATORY INFORMATION SYSTEM (LIS) TO CALCULATE INTERNATIONAL NORMALIZED RATIO (INR) RESULTS AFTER THE SAMPLES WERE PROCESSED CORRECTLY ON A BCS XP SYSTEM. THE CUSTOMER USED THE ISI VALUE OF 0.93 TO CALCULATE PATIENT SAMPLES' INR RESULTS INSTEAD OF THE ISI VALUE OF 1.09. THE CUSTOMER INDICATED THAT SINCE (B)(6) 2019, THEY REPORTED PATIENTS' INR RESULTS USING THE INCORRECT ISI VALUE DAILY FOR 3 WEEKS. AS PER THE CUSTOMER, 26 PATIENTS (41 SAMPLES) WERE IMPACTED BY THIS ISSUE. THE CUSTOMER DID NOT IDENTIFY WHICH PATIENTS WERE IMPACTED NOR THE DATES OF TESTING. THE PATIENT'S INR RESULTS WERE RECALCULATED USING THE CORRECT ISI VALUE. THE CORRECT INR RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER USING THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE TO CALCULATE INR RESULTS FOR PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433109 ↗
• MalfunctionMar 19, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEY'VE USED THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE IN A NON-SIEMENS LABORATORY INFORMATION SYSTEM (LIS) TO CALCULATE INTERNATIONAL NORMALIZED RATIO (INR) RESULTS AFTER THE SAMPLES WERE PROCESSED CORRECTLY ON A BCS XP SYSTEM. THE CUSTOMER USED THE ISI VALUE OF 0.93 TO CALCULATE PATIENT SAMPLES' INR RESULTS INSTEAD OF THE ISI VALUE OF 1.09. THE CUSTOMER INDICATED THAT SINCE (B)(6) 2019, THEY REPORTED PATIENTS' INR RESULTS USING THE INCORRECT ISI VALUE DAILY FOR 3 WEEKS. AS PER THE CUSTOMER, 26 PATIENTS (41 SAMPLES) WERE IMPACTED BY THIS ISSUE. THE CUSTOMER DID NOT IDENTIFY WHICH PATIENTS WERE IMPACTED NOR THE DATES OF TESTING. THE PATIENT'S INR RESULTS WERE RECALCULATED USING THE CORRECT ISI VALUE. THE CORRECT INR RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER USING THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE TO CALCULATE INR RESULTS FOR PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433108 ↗
• MalfunctionMar 19, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEY'VE USED THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE IN A NON-SIEMENS LABORATORY INFORMATION SYSTEM (LIS) TO CALCULATE INTERNATIONAL NORMALIZED RATIO (INR) RESULTS AFTER THE SAMPLES WERE PROCESSED CORRECTLY ON A BCS XP SYSTEM. THE CUSTOMER USED THE ISI VALUE OF 0.93 TO CALCULATE PATIENT SAMPLES' INR RESULTS INSTEAD OF THE ISI VALUE OF 1.09. THE CUSTOMER INDICATED THAT SINCE (B)(6) 2019, THEY REPORTED PATIENTS' INR RESULTS USING THE INCORRECT ISI VALUE DAILY FOR 3 WEEKS. AS PER THE CUSTOMER, 26 PATIENTS (41 SAMPLES) WERE IMPACTED BY THIS ISSUE. THE CUSTOMER DID NOT IDENTIFY WHICH PATIENTS WERE IMPACTED NOR THE DATES OF TESTING. THE PATIENT'S INR RESULTS WERE RECALCULATED USING THE CORRECT ISI VALUE. THE CORRECT INR RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER USING THE INCORRECT INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE TO CALCULATE INR RESULTS FOR PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433107 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970431. One submission often covers many models, so check the product and lot details in each record.

• Z-0825-2016 · Jan 14, 2016 · Terminated
  BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANAL