Test, Thrombin Time
Hematology · 21 CFR 864.7875
Recent MDR events
15 adverse event reports on file
- TEST THROMBIN REAGENTOct 24, 2023MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2023-00019
- TEST THROMBIN REAGENTSep 6, 2023MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2023-00015
- BC THROMBIN REAGENTNov 2, 2017MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2017-00130
- BC THROMBIN REAGENTNov 1, 2017MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2017-00128
- BC THROMBIN REAGENTNov 1, 2017MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2017-00124
- BC THROMBIN REAGENTNov 1, 2017MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2017-00127
- BC THROMBIN REAGENTNov 1, 2017MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2017-00125
- BC THROMBIN REAGENTNov 1, 2017MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2017-00129
- BC THROMBIN REAGENTNov 1, 2017MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2017-00120
- BC THROMBIN REAGENTNov 1, 2017MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2017-00126
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- bioMerieuxTerminatedOct 28, 2004
MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
Z-0053-05 · View FDA record ↗ - bioMerieuxTerminatedOct 28, 2004
Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
Z-0054-05 · View FDA record ↗ - Dade Behring , Inc.TerminatedOct 5, 2004
BC Thrombin Reagent . Thrombin Time Test
The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
Z-0007-05 · View FDA record ↗ - Siemens Healthcare DiagnosticsTerminatedUnknown
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and
The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).
Z-0827-2018 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Helena Laboratories, Corp.
BEAUMONT, TX, US
Diagnostica Stago, Inc.
PARSIPPANY, NJ, US
Diagnostica Stago - Taverny
Taverny Val-d'Oise, FR
R2 Diagnostics, Inc.
SOUTH BEND, IN, US
Instrumentation Laboratory Co. - Devens
Devens, MA, US
510(k) clearances
20 clearances for this product code
- R2 Diagnostics, Inc.Dec 12, 2005
K050817 · T-TEK
- Sigma Diagnostics, Inc.Oct 15, 1998
K982209 · ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
- Behring Diagnostics, Inc.May 19, 1997
K970645 · BC THROMBIN REAGENT
- Biomerieux Vitek, Inc.Apr 21, 1994
K925493 · BIOMERIEUX HEMOLAB THROMBICALCI-TEST
- Behring Diagnostics, Inc.May 14, 1993
K930157 · TEST THROMBIN
- Medical Laboratory Automation Systems, Inc.Sep 29, 1992
K923220 · THROMBIN CLOT TIME TEST PROCEDURE
- Helena LaboratoriesMay 1, 1992
K920147 · THROMBIN CLOTTING TIME REAGENT
- International Technidyne Corp.Feb 5, 1990
K900126 · TT AND HNTT BY HEMOCHRON