Coagulation Factor IX Deficient Plasma 10446414Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842768011023), received between Sep 19, 2018 and Sep 19, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K924396); 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED COAGULATION FACTOR IX (FACTOR IX) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP INSTRUMENT, USING THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT. THE SAMPLE WAS REPEATED USING A NON-SIEMENS METHODOLOGY, RESULTING LOWER. ON (B)(6) 2017, THE SAMPLE WAS REPEATED USING THE INITIAL REAGENT LOT, RESULTING IN DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS. THE PATIENT BLOOD WAS REDRAWN AND THE NEW SAMPLE WAS RUN MULTIPLE TIMES, USING THE SAME REAGENT LOT ON (B)(6) 2017 AND (B)(6) 2017, RESULTING IN OTHER DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS. THE REDRAWN SAMPLE WAS ALSO REPEATED USING A NON-SIEMENS METHODOLOGY, RESULTING LOWER. THE CUSTOMER INDICATED THAT SOME OF THE RESULTS DETERMINED BY THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE CUSTOMER ALSO STATED THAT CORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7890957 ↗
• MalfunctionSep 19, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED COAGULATION FACTOR IX (FACTOR IX) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP INSTRUMENT, USING THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT. THE SAMPLE WAS REPEATED USING A NON-SIEMENS METHODOLOGY, RESULTING LOWER. ON (B)(6) 2017, THE SAMPLE WAS REPEATED USING THE INITIAL REAGENT LOT, RESULTING IN DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS. THE PATIENT BLOOD WAS REDRAWN AND THE NEW SAMPLE WAS RUN MULTIPLE TIMES, USING THE SAME REAGENT LOT ON (B)(6) 2017 AND (B)(6) 2017, RESULTING IN OTHER DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS. THE REDRAWN SAMPLE WAS ALSO REPEATED USING A NON-SIEMENS METHODOLOGY, RESULTING LOWER. THE CUSTOMER INDICATED THAT SOME OF THE RESULTS DETERMINED BY THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE CUSTOMER ALSO STATED THAT CORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7890955 ↗
• MalfunctionSep 19, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED COAGULATION FACTOR IX (FACTOR IX) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM, USING THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING A NON-SIEMENS METHOD AND ON A BCS XP SYSTEM, USING THE SAME COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT LOT AND A NON-SIEMENS REAGENT. THE RESULTS OBTAINED USING THE NON-SIEMENS REAGENT RECOVERED LOWER THAN MOST RESULTS OBTAINED USING THE SIEMENS REAGENT. THE SAMPLE WAS ALSO SENT TO AN ALTERNATE LAB, WHERE IT WAS REPEATED USING A NON-SIEMENS METHOD, RESULTING LOWER. THE LOWER RESULTS MATCHED THE CLINICAL PICTURE FOR THE PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7890954 ↗
• MalfunctionSep 19, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED COAGULATION FACTOR IX (FACTOR IX) RESULTS WERE OBTAINED ON A PATIENT SAMPLE(S) ON A BCS XP SYSTEM USING THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT. THE CUSTOMER INDICATED THAT ONE OF THE DISCORDANT, FALSELY ELEVATED RESULTS DETERMINED BY THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT WAS REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE CUSTOMER REPORTED THE CORRECT RESULT TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING A NON-SIEMENS METHOD AND ON A BCS XP SYSTEM, USING THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT LOT AND A NON-SIEMENS REAGENT. THE RESULTS OBTAINED USING THE NON-SIEMENS REAGENT RECOVER LOWER THAN MOST RESULTS OBTAINED USING THE SIEMENS REAGENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7890952 ↗
• MalfunctionSep 19, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED COAGULATION FACTOR IX (FACTOR IX) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A BCS XP INSTRUMENT, USING THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT. THE SAMPLE WAS REPEATED USING A NON-SIEMENS METHODOLOGY, RESULTING LOWER. ON (B)(6) 2017, THE SAMPLE WAS REPEATED USING THE INITIAL REAGENT LOT, RESULTING IN DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS. THE PATIENT BLOOD WAS REDRAWN AND THE NEW SAMPLE WAS RUN MULTIPLE TIMES, USING THE SAME REAGENT LOT ON (B)(6) 2017 AND (B)(6) 2017, RESULTING IN OTHER DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS. THE REDRAWN SAMPLE WAS ALSO REPEATED USING A NON-SIEMENS METHODOLOGY, RESULTING LOWER. THE CUSTOMER INDICATED THAT SOME OF THE RESULTS DETERMINED BY THE COAGULATION FACTOR IX DEFICIENT PLASMA REAGENT WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE CUSTOMER ALSO STATED THAT CORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FACTOR IX RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7890948 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924396. One submission often covers many models, so check the product and lot details in each record.

• Z-1713-2015 · May 11, 2015 · Terminated
  Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulom
• Z-1374-05 · Jul 8, 2005 · Terminated
  Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test