Berichrom® Heparin 10446620Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842768012945), received between Oct 23, 2017 and Aug 23, 2019 — classified as 7 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  FIVE DISCORDANT, FALSELY LOW HEPARIN RESULTS AND ONE DISCORDANT, FALSELY HIGH HEPARIN RESULT WERE OBTAINED ON SIX PATIENT SAMPLES ON A BCS XP SYSTEM USING BERICHROM HEPARIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). TWO OF THE AFFECTED PATIENTS HAD THEIR HEPARIN DOSE INCREASED DUE TO THE DISCORDANT, FALSELY LOW HEPARIN RESULTS. THE PHARMACY LATER QUESTIONED THE REPORTED RESULTS. THE PATIENTS WERE LATER REDRAWN AND RETESTED FOR HEPARIN, RESULTING EITHER HIGHER OR LOWER, RESPECTIVELY. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES FOR ANY OF THE SIX PATIENTS DUE TO THE DISCORDANT, FALSELY LOW HEPARIN RESULTS AND THE DISCORDANT, FALSELY HIGH HEPARIN RESULT. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED FOR THE TWO PATIENTS WHO RECEIVED AN INCREASE IN HEPARIN DOSE DUE TO THE DISCORDANT, FALSELY LOW HEPARIN RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925596 ↗
• MalfunctionMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW HEPARIN UNFRACTIONATED (UF) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE BCS XP SYSTEM USING THE BERICHROM HEPARIN REAGENT. THESE RESULTS WERE AUTOVERIFIED BY THE SYSTEM AND SENT TO THE HOSPITAL'S LABORATORY INFORMATION SYSTEM (LIS). THE CUSTOMER NOTICED THAT THESE RESULTS WERE DISCORDANT BEFORE THEY WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPLACED THE REAGENTS WITH FRESH REAGENTS AND RERAN THE SAMPLES; THE REPEAT RESULTS WERE HIGHER THAN THE INITIAL RESULTS AND 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, FALSELY LOW HEPARIN UF RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7500805 ↗
• MalfunctionFeb 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEPARIN UNFRACTIONATED (UF) RESULTS, FLAGGED WITH "RESULTS ABOVE MEASUREMENT RANGE", WERE OBTAINED ON 2 PATIENT SAMPLES ON THE BCS XP SYSTEM, USING THE BERICHROM HEPARIN REAGENT. THE SAME SAMPLES WERE RERUN, USING A USER DEFINED METHOD (UDM) OF THE BERICHROM HEPARIN REAGENT, ON THE SAME SYSTEM, RESULTING LOWER. SAMPLE 822 WAS MANUALLY DILUTED WITH STANDARD HUMAN PLASMA (SHP) AND RUN USING THE SIEMENS' APPLICATION OF THE BERICHROM HEPARIN REAGENT, RESULTING HIGHER THAN THE REPEAT RESULT. THE RESULT OBTAINED USING THE MANUAL DILUTION WAS NOT REPORTED TO THE PHYSICIAN(S). THE OPERATOR INDICATED THAT THE PATIENT OF SAMPLE 822 WAS POTENTIALLY REDRAWN AND RUN AT AN ALTERNATE LAB, RECOVERING IN A RESULT OF 0.91 IU/ML. THE OPERATOR INDICATED THAT THE EXPECTED RESULTS FOR THESE PATIENTS ARE UNKNOWN AND THAT NO CORRECTED REPORT WAS REQUIRED SINCE THEY DID NOT REPORT ANY DISCORDANT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT HEPARIN UF RESULTS OBTAINED ON THESE SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7234639 ↗
• MalfunctionFeb 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEPARIN UNFRACTIONATED (UF) RESULT, FLAGGED WITH "RESULT ABOVE REFERENCE RANGE/CUT-OFF", WAS OBTAINED ON A PATIENT SAMPLE ON THE BCS XP SYSTEM, USING A USER DEFINED METHOD (UDM) OF THE BERICHROM HEPARIN REAGENT. THE SAME SAMPLE WAS RERUN, USING THE UDM AND THE SIEMENS' APPLICATION OF THE ASSAY, ON THE SAME SYSTEM. THE RESULT OBTAINED USING THE SIEMENS' APPLICATION RECOVERED HIGHER THAN THE INITIAL RESULT AND WAS FLAGGED, WHILE THE RESULT OBTAINED USING THE UDM RECOVERED LOWER THAN THE INITIAL RESULT. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT'S BLOOD WAS REDRAWN AND RUN AT AN ALTERNATE LAB, ON AN ALTERNATE BCS XP SYSTEM, RECOVERING IN A RESULT OF 0.19 IU/ML. IT IS UNKNOWN IF THIS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE EXPECTED RESULT FOR THIS PATIENT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT HEPARIN UF RESULTS OBTAINED ON SAMPLES FROM THIS PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7234637 ↗
• MalfunctionJan 2, 2018Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW HEPARIN UNFRACTIONATED (UF) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-1500 SYSTEM. THIS RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS SENT TO ALTERNATE FACILITY AND TESTED FOR HEPARIN UF. AN EXPECTED, HIGHER HEPARIN UF RESULT WAS OBTAINED ON THE PATIENT SAMPLE. A CORRECTED REPORT WAS NOT PROVIDED FOR THIS PATIENT. THE PATIENT'S HEPARIN TREATMENT WAS NOT ADJUSTED DUE TO THE DISCORDANT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HEPARIN UF RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7158642 ↗
• MalfunctionDec 27, 2017Imprecision; Low Test Results; Imprecision; Low Test Results

  IMPRECISE AND OUT OF RANGE HEPARIN UNFRACTIONATED (UF) QUALITY CONTROL (QC) RESULTS WERE OBTAINED ON THE SYSMEX CA-1500 SYSTEM. DURING THIS TIME, A PATIENT SAMPLE WAS TESTED FOR HEPARIN UF, RESULTING IN A DISCORDANT, FALSELY LOW HEPARIN UF RESULT. THIS RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE PATIENT'S BLOOD WAS REDRAWN AND RUN ON AN ALTERNATE SYSTEM, SYSMEX CA-1500 SYSTEM, USING SAME REAGENT LOT. A HIGHER HEPARIN UF RESULT, WITHIN THERAPEUTIC RANGE, WAS OBTAINED USING THE ALTERNATE SYSTEM. IT IS UNKNOWN IF THE REDRAWN RESULT WAS THE CORRECT RESULT AS THE OPERATOR WAS ALSO EXPERIENCING ISSUES WITH THE ALTERNATE SYSTEM. THE OPERATOR INDICATED THAT A CORRECTED REPORT WAS PROVIDED FOR THIS PATIENT AS THE PHARMACY INDICATED THAT THE PATIENT WAS ON HEPARIN TREATMENT WHEN THE DISCORDANT RESULT WAS REPORTED. HOWEVER, THE CORRECTED RESULT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HEPARIN UF RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7149214 ↗
• MalfunctionOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW HEPARIN UNFRACTIONATED (UF) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE BCS XP SYSTEM. IT IS UNKNOWN WHETHER ALL OF THE DISCORDANT RESULTS WERE FLAGGED BY THE SYSTEM. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER INDICATED THAT THEY RERAN THE SAME SAMPLE ON THE SAME INSTRUMENT UNTIL THEY OBTAINED A RESULT THAT MATCHED THE PATIENT'S CLINICAL HISTORY. THE REPEATED RESULTS RECOVERED HIGHER AND THE CUSTOMER REPORTED THE HIGHEST FLAGGED RESULT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HEPARIN RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6970286 ↗