HemosIL SynthASil 00020006800Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08426950078920), received between Sep 5, 2024 and May 4, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 11, 2025Class IIOpen, Classified

   Potential for microbial contamination.

   Z-1095-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Device Ingredient or Reagent Problem

  ON (B)(6), 2026, ERRONEOUS RESULTS WERE REPORTED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) AND PROTHROMBIN TIME (PT) FOR 18 PATIENT SAMPLES TESTED ON AN ACL TOP 500 CTS ANALYZER (SN (B)(6) USING HEMOSIL SYNTHASIL (LOT N0350874) AND HEMOSIL READIPLASTIN 20 ML (LOT N1248407). DURING THE EVENT PERIOD, ADDITIONAL PATIENT SAMPLES WERE TESTED USING THE SAME REAGENT LOTS; HOWEVER, THOSE RESULTS DID NOT REQUIRE CORRECTION. A TOTAL OF 50 PATIENT RESULTS WERE RETROSPECTIVELY REVIEWED TO ASSESS POTENTIAL IMPACT. FIRST OCCURRENCE (10:15 AM - 2:00 PM) ON 06APR2026: UNUSUALLY LOW AND FAILED PT AND APTT RESULTS WERE INITIALLY OBSERVED. QUALITY CONTROL (QC) WAS NOT RUN AT THE TIME THE ATYPICAL RESULTS WERE FIRST NOTED. ONCE THE ISSUE WAS RECOGNIZED, ENHANCED CLEANING OF ALL PROBES WAS PERFORMED, FOLLOWED BY QC TESTING. PT REAGENT QC INITIALLY FAILED LOW BUT PASSED UPON REPEAT TESTING AND MET LABORATORY-DEFINED ACCEPTANCE CRITERIA. APTT QC WAS WITHIN ACCEPTABLE LABORATORY RANGES ON INITIAL TESTING. SECOND OCCURRENCE (5:00 PM - 7:30 PM) ON 06APR2026: DURING THIS PERIOD, PT REAGENT QC REMAINED WITHIN LABORATORY-DEFINED ACCEPTABLE RANGES. APTT QC VALUES RECOVERED BUT REMAINED AT THE LOW END OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072477 ↗
• MalfunctionApr 14, 2026Device Ingredient or Reagent Problem

  ON (B)(6) 2026, THE CUSTOMER REPORTED DISCREPANT PT AND PTT PATIENT RESULTS GENERATED ON ACL TOP 550 CTS SN (B)(6), (PN 00000280045) AND ANOTHER ANALYZER USING HEMOSIL SYNTHASIL LOT N0754328 (PN 00020006800) AND HEMOSIL RECOMBIPLASTIN 2G (20ML), LOT N0159343, (PN 00020003050). USER REPORTED MULTIPLE ERRONEOUS PT/APTT RESULTS OVER A TWO-DAY PERIOD, WITH 60 CORRECTED REPORTS GENERATED AND 130 ADDITIONAL SAMPLES CANCELED DUE TO THE SAMPLES BEING TOO OLD TO RETEST. ALL ERRONEOUS RESULTS WERE LOWER THAN THE CORRECTED RESULTS. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879293 ↗
• MalfunctionApr 1, 2026Device Ingredient or Reagent Problem; Installation-Related Problem

  ON (B)(6) 2026, SIX PATIENT SAMPLES GENERATED ERRONEOUSLY LOW APTT RESULTS WHEN TESTED WITH HEMOSIL SYNTHASIL LOT N1046401 ON AN ACL TOP 300 CTS (SN (B)(6)). THE SAMPLES WERE RERUN AND GENERATED HIGHER RESULTS, AFTER WHICH CORRECTED PATIENT REPORTS WERE ISSUED. DURING TROUBLESHOOTING FOR CUVETTE SHUTTLE MOVEMENT ERRORS, IT WAS DETERMINED THAT CUVETTES HAD BEEN LOADED UPSIDE DOWN. QUALITY CONTROL AUTO-EXECUTED AND FAILED LOW FOR BOTH LEVELS. SOON AFTER, THE APTT-SS REAGENT GENERATED A "LEVEL LOW" WARNING; THE REAGENT WAS REPLACED AND QC PASSED WITHIN THE EXPECTED RANGE. SERVICE WAS DISPATCHED TO THE SITE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754148 ↗
• MalfunctionFeb 10, 2026Device Ingredient or Reagent Problem

  ON (B)(6) 2026, THE CUSTOMER REPORTED ERRONEOUSLY LOW APTT RESULTS (<21.0 SECONDS), BELOW THEIR ESTABLISHED CUTOFF, FOR FOUR PATIENT SAMPLES WHEN TESTING WITH HEMOSIL SYNTHASIL, LOT N0754328, ON AN ACL TOP 350 CTS (SERIAL NUMBER (B)(6). FOR SAMPLE (B)(6), TESTING WAS PERFORMED AT 10:55 AND 11:16 ON THE SAME DAY, WITH BOTH APTT RESULTS REPORTED AS <21.0 SECONDS. THE USER THEN REPEATED THE TEST ON ANOTHER ANALYZER (ACL TOP, SERIAL NUMBER (B)(6), WHICH PRODUCED AN APTT VALUE OF 30.2 SECONDS. A CORRECTED PATIENT REPORT WAS SUBSEQUENTLY ISSUED. A SERVICE VISIT WAS DISPATCHED TO EVALUATE THE INSTRUMENT. NO HARDWARE RELATED ISSUES WERE IDENTIFIED, AND SYSTEM VERIFICATION PASSED. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308474 ↗
• MalfunctionDec 11, 2025Microbial Contamination of Device; Microbial Contamination of Device

  ON 10/10/2025, INSTRUMENTATION LABORATORY RECEIVED A CUSTOMER COMPLAINT REGARDING CONTAMINATION ISSUES WITH VIALS OF HEMOSIL SYNTHASIL LOT N1136730. THE CUSTOMER REPORTED MOLD GROWTH IN REAGENT. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783331 ↗
• MalfunctionDec 11, 2025Microbial Contamination of Device; Microbial Contamination of Device

  ON 07/02/2025, INSTRUMENTATION LABORATORY RECEIVED A CUSTOMER COMPLAINT REGARDING MICROBIAL CONTAMINATION ISSUES WITH VIALS OF HEMOSIL SYNTHASIL LOT N1136730. CUSTOMER NOTICED CONTAMINATION WHEN QC RESULTS FAILED. CUSTOMER DETERMINED THAT THE APTT REAGENT HAD MICROBIAL CONTAMINANT IN IT. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783170 ↗
• MalfunctionDec 11, 2025Microbial Contamination of Device; Microbial Contamination of Device

  ON 03/21/2025, INSTRUMENTATION LABORATORY RECEIVED A CUSTOMER COMPLAINT REGARDING CONTAMINATION ISSUES WITH VIALS OF HEMOSIL SYNTHASIL LOT N1136730. CUSTOMER NOTICED CHUCKS OF "CLOUB" FORMED INSIDE THE APTT REAGENT BOTTLES. THE CUSTOMER THEN INSPECTED ALL REMAINING APTT STOCK AND DETERMINED THAT 10 VIAL BOXES WERE CONTAMINATED. THERE WAS NO NEGATIVE PATIENT IMAPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783137 ↗
• MalfunctionDec 11, 2025Microbial Contamination of Device; Microbial Contamination of Device

  ON 03/21/2025, INSTRUMENTATION LABORATORY RECEIVED A CUSTOMER COMPLAINT REGARDING MICROBACTERIAL CONTAMINATION WITH VIALS OF HEMOSIL SYNTHASIL LOT N1136730. THE CUSTOMER RANDOMLY INSPECTED 15 OUT OF 75 VIAL BOXES AND DETERMINED THAT 1 OR 2 VIALS IN EACH BOX WERE CONTAMINATED. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783078 ↗
• MalfunctionDec 11, 2025Microbial Contamination of Device; Microbial Contamination of Device

  ON 03/19/2025, INSTRUMENTATION LABORATORY RECEIVED A CUSTOMER COMPLAINT REGARDING APPEARANCE ISSUES WITH VIALS OF HEMOSIL SYNTHASIL LOT: N1136730. CUSTOMER NOTICED CONTAMINATION WHEN THREE LEVELS OF QC RESULTS WERE OUT OF RANGE. UPON INSPECTION, THE CUSTOMER OBSERVED A CLOUD OF WHITE CLUMPS INSIDE THE APTT REAGENT VIAL. THE CUSTOMER THEN INSPECTED ALL REMAINING APTT STOCK AT THEIR FACILITY AND DETERMINED THAT OUT OF 33 BOXES, 9 VIALS WERE CONTAMINATED. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783049 ↗
• MalfunctionDec 11, 2025Microbial Contamination of Device; Microbial Contamination of Device

  ON 03/04/2025, INSTRUMENTATION LABORATORY RECEIVED A CUSTOMER COMPLAINT REGARDING APPEARANCE ISSUES WITH VIALS OF HEMOSIL SYNTHASIL LOT: N1136730. THE CUSTOMER REPORTED VISIBLE IMPURITIES IN THE VIALS AND INDICATED THAT THE QC RESULT WAS OUT OF RANGE. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783038 ↗
• MalfunctionNov 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A COMPLAINT WAS SUBMITTED ON HEMOSIL SYNTHASIL, PART NUMBER 00020006800, LOT N0441431. THE CUSTOMER OBSERVED DISCREPANT APTT RESULTS MEASURED ON ACL TOP 750 LAS (SN (B)(6)). A CORRECTED REPORT WAS GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489860 ↗
• MalfunctionOct 28, 2025Device Ingredient or Reagent Problem; No Apparent Adverse Event; Device Ingredient or Reagent Problem; No Apparent Adverse Event

  ON SATURDAY, (B)(6) 2025, CUSTOMER REPORTED ERRONEOUS APTT RESULTS FOR MULTIPLE PATIENTS. THE ISSUE WAS IDENTIFIED WHEN PATIENT RESULTS SHOWED UNUSUALLY LOW VALUES (IN THE LOW 20 SECONDS RANGE). TWO SYSTEM ERRORS WERE OBSERVED: "PROBE REAGENT INSUFFICIENT VOLUME IN CLEAN CUP (2076)" AND "CLEAN ASPIRATION ERROR (1449)." CUSTOMER REPLACED REAGENT WHICH RESOLVED THE ISSUE. REPEATED TESTING OF PATIENT SAMPLES YIELDED RESULTS WITHIN THE NORMAL RANGE. PATIENT IMPACT UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403066 ↗
• MalfunctionAug 27, 2025Low Test Results; Low Test Results

  ERRONEOUS APTT TEST RESULTS CAUSED BY SUSPECTED PROBLEMATIC REAGENT. THE OPERATOR PLACED TWO SETS OF APTT REAGENTS (THE SECOND SET WAS BRAND NEW). THE INITIAL APTT QUALITY CONTROL WAS NORMAL, WITH A RESULT OF 30.2 SECONDS (TARGET VALUE 29.0 SECONDS). WHEN THE FIRST SET OF APTT REAGENTS WAS EXHAUSTED AND THE SECOND SET WAS SWITCHED IN, STARTING FROM SAMPLE NUMBER (B)(6), ALL PATIENT SAMPLE APTT RESULTS WERE SIGNIFICANTLY LOWER THAN NORMAL. AFTER NOTICING THE ABNORMAL RESULTS, THE OPERATOR REPLACED THE SUSPECTED PROBLEMATIC REAGENT AND RETESTED. RETESTING SHOWED LARGE DISCREPANCIES IN RESULTS, CONFIRMING REAGENT ISSUES. NO ADVERSE EVENT OR PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902456 ↗
• MalfunctionAug 20, 2025Missing Test Results; Missing Test Results

  A COMPLAINT WAS SUBMITTED ON HEMOSIL SYNTHASIL, PN 00020006800, LOT N1147356 INDICATING ERRONEOUS APTT RESULTS GENERATED ON ACL TOP 350 CTS, SN (B)(6), ON JULY 20, 2025 AT 20:29 AND 20:52. THE ANALYZER FAILED TO PRODUCE NUMERICAL APTT VALUES. HEPARIN CONTAMINATION WAS INITIALLY SUSPECTED, PROMPTING A REDRAW OF THE PATIENT SAMPLE AFTER ENSURING THAT HEPARIN HAD BEEN SUSPENDED. HOWEVER, THE REDRAW SPECIMEN ALSO FAILED TO YIELD A NUMERICAL RESULT.

  Patient problems: Insufficient Information

  MAUDE report 22853524 ↗
• MalfunctionAug 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A COMPLAINT WAS RECEIVED REGARDING HEMOSIL SYNTHASIL (LOT N0844847) USED ON ACL TOP 750 LAS (B)(6), WHERE APTT RESULTS WERE OBSERVED SHORTER THAN EXPECTED FOR HEMOSIL NORMAL CONTROL ASSAYED (LOT N0824873) AND HEMOSIL LOW ABNORMAL CONTROL ASSAYED (LOT N0532071). LABORATORY STAFF SUSPECTED REAGENT VIAL CONTAMINATION. REPLACING THE REAGENT RESTORED EXPECTED RECOVERIES. SUBSEQUENT INVESTIGATION (7/31/2025) CONFIRMED TWELVE PATIENT SAMPLES TESTED ON (B)(6) 2025 ALSO PRODUCED SHORTENED APTT RESULTS. RESULTS WERE CORRECTED AFTER RETESTING ON A SEPARATE ACL TOP 750 LAS ANALYZER (B)(6). NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852973 ↗
• MalfunctionAug 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A PTT SPECIMEN WAS INITIALLY ANALYZED AT 5:56 AM ON ACL ANALYZER WITH SERIAL NUMBER (B)(6), PRODUCING A RESULT OF 102.1 SECONDS. LATER IN THE DAY, AT APPROXIMATELY 3:00 PM, THE SAME SPECIMEN WAS REANALYZED ON A DIFFERENT ANALYZER (SN: (B)(6)) AND YIELDED A RESULT OF 23.5 SECONDS. THIS DISCREPANCY WAS BROUGHT TO ATTENTION FOLLOWING A PHYSICIAN INQUIRY REGARDING THE UNEXPECTEDLY PROLONGED INITIAL RESULT. TO FURTHER INVESTIGATE, A SUBSEQUENT SPECIMEN WAS COLLECTED FROM THE SAME PATIENT AND TESTED AT 3:30 PM, RESULTING IN VALUES OF 23.9 AND 24.3 SECONDS, CONSISTENT WITH THE REPEAT RESULT AND WITHIN THE EXPECTED RANGE. ALL QUALITY CONTROL (QC) DATA INCLUDING NORMAL QC (LOT: N1046514) AND ABNORMAL QC (LOT: N0945748) WAS WITHIN ACCEPTABLE LIMITS BOTH BEFORE AND AFTER THE INCIDENT. THE PTT SYNTHASIL REAGENT LOT IN USE WAS N0542241. THERE WAS NO IMPACT ON PATIENT CARE, AS THE ERRONEOUS RESULT WAS IDENTIFIED AND CORRECTED BEFORE ANY CLINICAL ACTION WAS TAKEN. IT WAS ALSO NOTED THAT THE CUSTOMER SITE HAD NOT RECEIVED PREVENTIVE MAINTENANCE (PM) SERVICE SINCE JUNE 2023. THE CUSTOMER WAS ADVISED THAT THEIR ACCOUNT IS BILLABLE AND THAT A PURCHASE ORDER (PO) WILL BE REQUIRED TO SCHEDULE SERVICE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731164 ↗
• MalfunctionJul 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  A COMPLAINT WAS SUBMITTED ON HEMOSIL SYNTHASIL, PART NUMBER 00020006800, LOT N0441431. ON (B)(6) 2025, THE CUSTOMER OBSERVED A DISCREPANCY IN MEASUREMENTS FOR SYNTHASIL WITH A PATIENT SAMPLE MEASURED ON ACL TOP 750 LAS - SN (B)(6), IN COMPARISON TO MEASUREMENT ON ACL TOP 750 CTS - SN (B)(6). THERE WAS NO PATIENT IMPACT AND NO CHANGE TO PATIENT THERAPY BASED ON THESE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540453 ↗
• InjurySep 5, 2024Moisture or Humidity Problem; Insufficient Device Problem Information; Moisture or Humidity Problem; Insufficient Device Problem Information

  A CUSTOMER COMPLAINT WAS SUBMITTED ON HEMOSIL SYNTHASIL (PART NO. 0020006800, LOT NO. N0532089), INDICATING THAT THERE WERE 32 INCORRECT APTT PATIENT RESULTS REPORTED BY THE ACL TOP 550 CTS (SERIAL NO. 19071186). QUALITY CONTROL RESULTS PRIOR TO PATIENT TESTING WERE WITHIN ACCEPTANCE CRITERIA. HOWEVER, WHEN QUALITY CONTROLS WERE RUN AFTER PATIENT TESTING, THE RESULTS WERE OUTSIDE OF ACCEPTANCE CRITERIA. THE USER REPLACED THE REAGENTS, AND THEN QUALITY CONTROLS CAME BACK INTO RANGE. THE PATIENTS RUN DURING THE TIME PERIOD WERE RERUN AND 32 CORRECTED PATIENT REPORTS WERE ISSUED. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20150232 ↗