TransFix/EDTA Vacuum Blood Collection Tube KC1030Recalls & reported problems
Caltag Medsystems Limited · TransFix/EDTA Vacuum Blood Collection Tube to directly draw and stabilize whole blood for flow cytometric analysis. · Class 2
- 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 05060531711603), received between Jul 23, 2024 and Jul 23, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Missing Information1
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.
MalfunctionJul 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ISSUE OF BLOOD CLOTTING IN TUBES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19805734 ↗MalfunctionJul 23, 2024Missing Information; Missing Information
THE LINE OF THE MANUFACTURERS' ADDRESS '11 LITTLE BALMER' WAS MISSING FROM THE LABELS, TVT-03-1 FOIL POUCH REV 5, 2023-08. TVT-03-2 FOIL POUCH REV 6, 2023-08. TF-01-10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19804846 ↗
Other Tubes, Vacuum Sample, With Anticoagulant devices
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- BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes 366643Becton, Dickinson U.K. Limited · Tubes, vacuum sample, with anticoagulant124 reports
- Cyto-Chex BCT 218980Streck, Inc. · Tubes, Vacuum Sample, With Anticoagulant1 recall0 reports
- Cyto-Chex BCT 213559Streck, Inc. · Tubes, Vacuum Sample, With Anticoagulant1 recall0 reports
- Vacuette 454334Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
- Vacuette 454332Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
- BD MiniDraw™ Finger Sleeve, Extra-Large 366616Becton, Dickinson And Company · Tubes, vacuum sample, with anticoagulant25 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.