HemosIL AcuStar HIT-IgG (PF4-H) 0009800127Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08426951126545), received between Apr 2, 2025 and Sep 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 reports).

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

1 other recall cover devices cleared under the same FDA submission (K170854); 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.

Recalls naming this device

1. Sep 3, 2026Open, Classified

   Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

   Z-0001-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859735 ↗
• MalfunctionAug 20, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50347530 ↗
• MalfunctionJun 6, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2025, THE CUSTOMER REPORTED 3 PATIENTS WITH DISCREPANT RESULTS BETWEEN HEMOSIL ACUSTAR HIT IGG (PF4-H) (NEGATIVE RESULTS) AND ELISA METHOD (POSITIVE RESULTS). NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161249 ↗
• MalfunctionApr 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER REPORTS 2 DISCREPANT HIT PATIENT RESULTS WITH ACL TOP. NO FALSE RESULTS WERE REPORTED. NO PATIENT IMPACT AS RESULTS FROM THE ACL ACUSTAR WERE NOT RELEASED DUE TO ON GOING VALIDATIONS STUDIES. 2 PATIENT SAMPLES RESULTED AS NEGATIVE ON THE ACUSTAR. SAME SAMPLES WERE RUN ON THE ACL TOP AND RESULTED AS POSITIVE. SAMPLES WERE SENT OUT FOR SRA-BOTH SAMPLES RESULTED AS POSITIVE. PATIENTS HAVE BEEN CONFIRMED TO CLINICALLY HAVE HIT. BOTH PATIENTS WERE ON HEPARIN AT TIME OF TESTING. PATIENT FROM 1/20 HAD A PLATELET COUNT OF 200 DROP TO 65. PATIENT FROM 2/27 HAD A PLATELET COUNT OF 200 DROP TO 87. PLATELET COUNTS CAME BACK UP ONCE THE HEPARIN WAS STOPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752118 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170854. One submission often covers many models, so check the product and lot details in each record.

• Z-0002-2027 · Sep 3, 2026 · Open, Classified
  HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)