TEG5000 HEMOSTASIS SYSTEM 6211Recalls & reported problems
Haemonetics Corporation · DISPOSABLE CUPS & PINS, CLEAR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20812747018132), received between Dec 10, 2020 and Dec 10, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 16, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON NOVEMBER 11 2020, HAEMONETICS WAS NOTIFIED OF FALSE TEST RESULTS, WHICH OCCURRED POST PROCEDURE UTILIZING THE TEG SYSTEM IN DENMARK. AT THIS TIME THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH, HAEMONETICS IS AWAITING ADDITIONAL INFORMATION REGARDING MISDIAGNOSIS, AND PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10982361 ↗MalfunctionDec 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF FALSE TEST RESULTS WHICH OCCURRED POST PROCEDURE UTILIZING THE TEG SYSTEM IN (B)(6). AT THIS TIME THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH, HAEMONETICS IS AWAITING ADDITIONAL INFORMATION REGARDING MISDIAGNOSIS AND PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10982238 ↗
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- ACL ELITE 00000880311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- Hemochron Whole Blood Microcoagulation System ELITEAccriva Diagnostics Holdings, Inc. · System, Multipurpose For In Vitro Coagulation Studies2 deaths13 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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