HemosIL RecombiPlasTin 2G (8 mL) 00020002950Recalls & reported problems
Instrumentation Laboratory Company · HemosIL RecombiPlasTin 2G (8 mL) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950453079), received between Apr 29, 2025 and Apr 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A PATIENT WITH A HISTORY OF CABG AND MVR (2012), ON LONG-TERM ACITROM (3 MG/DAY), HYPERTENSION, AND DYSLIPIDEMIA, WAS ADMITTED ON (B)(6) 2025, WITH A LEFT-SIDED HYPERACUTE SMALL THALAMIC INFARCT. AFTER TREATMENT AND DISCHARGE, HE RETURNED FOR FOLLOW-UP ON (B)(6) 2025. HE HAS DONE PT AND APTT TEST ON 6TH OF APRIL 2025, AND HE GOT THE INR OF 6.2. INR VALUES VARIED SIGNIFICANTLY ACROSS DIFFERENT TESTING SITES: 6.2 (INITIAL), 3.47, AND 4.59, RAISING CONCERNS ABOUT RELIABILITY AND ANTICOAGULATION CONTROL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21929431 ↗
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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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