Berichrom® Antithrombin III (A) 10446672Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · Determination of the functional activity of antithrombin III (AT III) in human plasma · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768013461), received between Oct 30, 2017 and Oct 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Low Test Results3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2024Low Test Results; Low Test Results
THE CUSTOMER REPORTED A FALSELY DEPRESSED BERICHROM ANTITHROMBIN III (BERICHROM ATIII) RESULT THAT WAS OBTAINED ON A SYSMEX CS-5100 INSTRUMENT. THE INITIAL RESULT WAS REPORT TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL SYSMEX CS-5100 AND THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED BERICHROM ATIII RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20505976 ↗MalfunctionOct 22, 2024Low Test Results; Low Test Results
THE CUSTOMER REPORTED A FALSELY DEPRESSED BERICHROM ANTITHROMBIN III (BERICHROM ATIII) RESULT THAT WAS OBTAINED ON A SYSMEX CS-5100 INSTRUMENT. THE INITIAL RESULT WAS REPORT TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE SYSMEX CS-5100 AND THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED BERICHROM ATIII RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20505783 ↗MalfunctionOct 30, 2017Low Test Results; Low Test Results
A DISCORDANT, LOW BERICHROM ANTITHROMBIN III (ATIII) PATIENT SAMPLE RESULT OF <15% WAS GENERATED ON THE ATELLICA COAG 360 SYSTEM AND WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS TESTED AGAIN ON THE SAME SYSTEM AND AN ATIII RESULT OF 95.2% WAS GENERATED. THE SAME PATIENT SAMPLE WAS REPEATED ON A BCS XP SYSTEM AND AN ATIII RESULT (NOT PROVIDED BY CUSTOMER) WAS GENERATED THAT WAS CONSISTENT WITH THE 95.2% RESULT ON THE ATELLICA COAG 360 SYSTEM. ALL QUALITY CONTROL RESULTS WERE WITHIN RANGE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, LOW ATIII RESULT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6986810 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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