Factor VIII Chromogenic Assay 10445729Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842768004032), received between Nov 22, 2017 and Oct 24, 2025 — classified as 6 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K884544); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT INCREASED RESULTS OF COAGULATION FACTOR VIII / DADE ACTIN FS ACTIVATED PTT REAGENT ASSAY FOR ONE PATIENT WITH KNOWN HEMOPHILIA A ON THE CS-2500 SYSTEM USING APTT WITH FACTOR VIII. THE SAMPLE WAS REPEATED WITH AN ALTERNATE METHOD SIEMENS COAGULATION FACTOR VIII / FACTOR VIII CHROMOGENIC ASSAY AND RECOVERED LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377292 ↗
• MalfunctionJun 6, 2022High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED FACTOR VIII RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM USING FACTOR VIII CHROMOGENIC ASSAY. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). A SECOND SAMPLE FROM THE SAME PATIENT THAT WAS DRAWN AT THE SAME TIME WAS MEASURED FOR FACTOR VIII USING A NON-SIEMENS ASSAY, RECOVERING LOWER. IT IS UNKNOWN IF THIS LOWER RESULT WAS CONSIDERED TO BE CORRECT OR IF IT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO DISCORDANT FACTOR VIII RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604885 ↗
• MalfunctionMay 10, 2019Off-Label Use; Off-Label Use

  THE CUSTOMER REPORTED THAT SHE PIERCED HERSELF IN THE HAND DURING THE PREPARATION OF THE FACTOR X PART OF THE FACTOR VIII CHROMOGENIC ASSAY. PER THE PROCEDURE AT THE CUSTOMER SITE, THE FACTOR X REAGENT HAS TO BE DISSOLVED BY ADDING WATER USING A SYRINGE WITH AN INJECTION NEEDLE, WHICH HAS TO BE PIERCED THROUGH THE CLOSED REAGENT CAP. DURING THIS PROCEDURE, THE CUSTOMER PIERCED HERSELF IN THE HAND. THE CUSTOMER WAS WEARING PROTECTIVE GLOVES. THE CUSTOMER WENT TO A MEDICAL DOCTOR, BUT NO MEDICAL TREATMENT WAS REQUIRED. THERE ARE NO KNOWN REPORTS OF MEDICAL INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER PIERCING HERSELF IN THE HAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8600398 ↗
• MalfunctionNov 22, 2017High Test Results; High Test Results

  A DISCORDANT, HIGH FACTOR VIII PATIENT RESULT (CHROMOGENIC FACTOR VIII ASSAY) WAS GENERATED ON THE BCS XP SYSTEM COMPARED TO A CHROMOGENIC FACTOR VIII PATIENT RESULT GENERATED AT ANOTHER REFERENCE LAB (ESOTERIX). A DIFFERENT PATIENT SAMPLE (FROM THE SAME PATIENT) WAS USED AT ESOTERIX, BUT IT IS NOT KNOWN WHAT SYSTEM WAS USED. QUALITY CONTROLS WERE IN RANGE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, HIGH FACTOR VIII PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7053628 ↗
• MalfunctionNov 22, 2017High Test Results; High Test Results

  A DISCORDANT, HIGH FACTOR VIII PATIENT RESULT (CHROMOGENIC FACTOR VIII ASSAY) WAS GENERATED ON THE BCS XP SYSTEM COMPARED TO A CHROMOGENIC FACTOR VIII ASSAY PATIENT RESULT GENERATED AT ANOTHER REFERENCE LAB (ESOTERIX). A DIFFERENT PATIENT SAMPLE (FROM THE SAME PATIENT) WAS USED AT ESOTERIX, BUT IT IS NOT KNOWN WHAT SYSTEM WAS USED. FACTOR VIII ACTIVITY WAS ALSO HIGH ON THAT PATIENT SAMPLE ON THE BCS XP SYSTEM COMPARED TO THE FACTOR VIII ACTIVITY RESULT GENERATED AT THE REFERENCE LAB (ESOTERIX). QUALITY CONTROLS WERE IN RANGE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, HIGH FACTOR VIII PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7053625 ↗
• MalfunctionNov 22, 2017High Test Results; High Test Results

  A DISCORDANT, HIGH FACTOR VIII ACTIVITY PATIENT RESULT (CHROMOGENIC FACTOR VIII ASSAY) WAS GENERATED ON THE BCS XP SYSTEM COMPARED TO A CHROMOGENIC FACTOR VIII ACTIVITY PATIENT RESULT GENERATED AT ANOTHER REFERENCE LAB (ESOTERIX). A DIFFERENT PATIENT SAMPLE (FROM THE SAME PATIENT) WAS USED AT ESOTERIX, BUT IT IS NOT KNOWN WHAT SYSTEM WAS USED. QUALITY CONTROLS WERE IN RANGE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, HIGH FACTOR VIII ACTIVITY PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7053619 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K884544. One submission often covers many models, so check the product and lot details in each record.

• Z-0468-2016 · Nov 19, 2015 · Terminated
  Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency