Coagulation Factor VIII Deficient Plasma 10446411Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768010996), received between Jan 4, 2018 and Sep 17, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED COAGULATION FACTOR VIII DEFICIENT PLASMA RESULT ON A SYSMEX CN-6000 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO, BASED ON THE PATIENT'S SEVERE HEMOPHILIA CLASSIFICATION, QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE METHOD. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT AND ALIGNED WITH THE CLINICAL PICTURE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED COAGULATION FACTOR VIII DEFICIENT PLASMA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237310 ↗
• MalfunctionSep 13, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED FACTOR VIII RESULT ON A SYSMEX CN-6000 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO, BASED ON THE PATIENT'S SEVERE HEMOPHILIA CLASSIFICATION, QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FACTOR VIII RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211210 ↗
• MalfunctionJan 4, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  DISCORDANT COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULTS FOR ONE PATIENT WERE GENERATED ON THE BCS XP ANALYZER (SN (B)(4)). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. ALL QUALITY CONTROL (QC) WAS IN RANGE ON THIS BCS XP ANALYZER. THE SAME PATIENT SAMPLE WAS REPEATED ON THE SAME BCS XP ANALYZER AND DISCORDANT COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULTS WERE GENERATED ONCE AGAIN. NO DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS THEN RUN ON A CA-7000 ANALYZER AND ON A DIFFERENT BCS XP ANALYZER (SN (B)(4)). THE COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULTS GENERATED ON THE CA-7000 ANALYZER WERE NOT CONSIDERED DISCORDANT (MEAN OF 34.2%) AND CONSISTENT WITH THE PATIENT RESULTS GENERATED ON THE BCS XP ANALYZER SN (B)(4) (MEAN OF 33.2%). THE COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULT GENERATED ON THE BCS XP ANALYZER SN (B)(4) (MEAN OF 33.2%) WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT COAGULATION FACTOR VIII DEFICIENT PLASMA PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7165793 ↗

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